Persistent Holes in Coloplast Bags - Anyone Else?

Replies
58
Views
509
Worzie
Dec 31, 2024 3:32 am
Reply to Beth22

AlexT suggested possibly a dog or cat. I have had cats in the past and witnessed them biting potatoes and paper. They love to knead too. Would make sense with finding gravel or grit.

I'd think this forum would be a great place to poll this issue and, looking back at the past year of your posts asking about it, it doesn't appear to be as systemic. Have you asked on other forums? I'm only on one other that gets far fewer posts.

I think asking about your distributor is a valid question. Your point about the product never being in Coloplast's hands is exactly why the question is valid.

Last silly question, are there any signs of damage on the boxes?

Sticking with Coloplast, perhaps switch to another pouch? I'm not a big fan of the transparent bags. I like the gray nylon covers over the Sensura Mio.

Not having damages to the boxes would lead me to think it's a manufacturing issue too, especially if they are happening to the pouches in the middle of a box.

This has to be very frustrating after having put up with this for over a year!

Beth22
Dec 31, 2024 3:28 pm

It is very frustrating. And switching to another bag is not an option, as I have said earlier in my other posts. Coloplast is the only one I am not allergic to. I have tried literally every brand out there, and I dug deep. And as I have said before, which it doesn't seem that people read previous posts, but yes, I have tried other bags Coloplast has, and yes, the same thing. And no, if the boxes were damaged, I would have contacted my distribution company, as those damages they have to replace. And again, it is a manufacturer error; it's holes in the bag, it's happening during the making process. And no, it's not from the distribution company, and holes or any faulty issues with your bag is a manufacturer problem. Yes, I have had my bags shipped from various different places; no, it doesn't make a difference, same issue, and yes, I have gotten them straight from Coloplast, that's who replaces your bags when there is a manufacturer problem. And yes, they have tried shipping theirs from different warehouses, and no, it doesn't make a difference. It is a manufacturer problem. And the way my stoma is, I have to have a transparent pouch, and I prefer it that way, and when I want it covered, I have pouch covers.

This post was to let others know if there are holes in the bag so they could be aware, and if they are having weird leaks, they could have an idea of why, and to encourage others when and if they have this issue to call and let Coloplast know, and I was just curious if others were having any issues.

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Worzie
Dec 31, 2024 4:48 pm
Reply to Beth22

Do you have cats? Hardly something a manufacturer can control.

Sorry to have you reiterate. I'm really not interested in reading years' past posts to get answers to the previously asked multiple times question about animals.

w30bob
Dec 31, 2024 5:26 pm

Hi B,

There is one more option you probably haven't tried............and that's China. The Sensura Mio 2-piece uses the 'click' system, I think. If not, then whatever system they use has probably been copied by the Chinese so their bags will also fit your Mio baseplate/wafer/barrier. They're super cheap and you can hunt around on AliExpress to find exactly what you want. Even if you have to buy their bags with their baseplate, they're cheap enough. I did a really quick search and found a copy of the Mio click that I think is on your barrier/bag. I've bought stuff from AliExpress and it's safe. Stuff takes about a week to get to me here in Maryland; it would be a shorter time for those inland. Hunt around on there and you'll probably find a number of bags that will fit your Mio barrier. Order one or two just to see the quality and go from there.

https://www.aliexpress.us/item/3256807452304237.html?spm=a2g0o.productlist.main.17.465c2fccfbtrr8&algo_pvid=41a0b639-c592-4bc8-b437-d2193015f372&algo_exp_id=41a0b639-c592-4bc8-b437-d2193015f372-8&pdp_npi=4%40dis%21USD%214.35%214.35%21%21%214.35%214.35%21%402103244417356655542754491e1684%2112000041601954761%21sea%21US%213885449843%21X&curPageLogUid=nyiv3FAMPuy0&utparam-url=scene%3Asearch%7Cquery_from%3A&_gl=1*2el7kg*_gcl_aw*R0NMLjE3MzQxNzA1ODIuQ2p3S0NBaUE5dlM2QmhBOUVpd0FKcG5YdzlWMnRIY3BFWkNuV3U0LXFXcTlSOUxSckFVS1VKR2ZyaUFtTHhrdVpMdFFsdWhwb2lMZXFob0NmclVRQXZEX0J3RQ..*_gcl_dc*R0NMLjE3MzE3MzQ2NTAuQ2owS0NRaUFfOXU1QmhDVUFSSXNBQmJNU1B2LWZRWllrSkJPaHhsWDVkWC1fdVZoOGpCeDZxb0FiZ2tqTUhBYzFzcE1CSlNxbDVFdF9sRWFBdU9rRUFMd193Y0I.*_gcl_au*MTI3ODgzODMwMi4xNzMxNzA5NjM0*_ga*MTk4NTg1ODQ5NTEwNjAzMS4xNzE2MDAxMzE0NDEy*_ga_VED1YSGNC7*MTczNTY2NTU1Ny4xMTUuMC4xNzM1NjY1NTU3LjYwLjAuMA.

;O)

Beth22
Dec 31, 2024 8:53 pm
Reply to w30bob

Hey Bob, thanks for the idea. But I don't wear a two-piece; I wear a one-piece. And I have other medical expenses I have to pay for out of pocket, so buying bags on top of it is not something I can afford. But also, the point being is neither I nor anyone else should have to be in this situation, not with Coloplast, Hollister, Convetec, or any other brand, especially since this is our livelihood and it's products we physically need. So companies not listening to the patients when there is a problem, and companies taking away products that people have used for 15 plus years isn't right.

 

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aTraveler
Dec 31, 2024 9:03 pm

Beth, have you complained to the Better Business Bureau (BBB)? 🤔

This gets the attention of the company, and usually, they will respond and/or reach out to you.

I have had to take this approach on occasion with good outcomes.

Beth22
Jan 01, 2025 3:42 pm
Reply to aTraveler

A traveler, I was thinking of taking this as my next step. Wasn't sure if the BBB handles stuff like this. I have had to contact the BBB on completely different stuff with a hotel company. I found an email address for the CEO of Coloplast and wrote to him; he wrote back, and I replied again (just a day ago), waiting to hear a reply. If nothing comes of it from contacting the CEO, then I am going to have to contact the BBB. Thank you.

w30bob
Jan 01, 2025 3:46 pm
Reply to aTraveler

Hi A,

I thought the same thing a while back, but Coloplast isn't accredited with the BBB and is listed as an LLC, so they won't care what the BBB rates them, which it won't. "To become accredited, a business must agree to BBB Standards for Trust and pass BBB's vetting process." So basically, it's a dead end.

w30bob
Jan 01, 2025 4:26 pm
Reply to Beth22

Hi B,

Sorry... this thread is getting long, and I missed the part about you only using a one-piece. I guess I'd have to ask why you couldn't wear a two-piece if it solved the bag hole problem? Maybe you already explained that too... sorry if that's the case.

The problem here is that it seems you are the only person having this problem with Coloplast bags. I searched the other ostomy sites and then did a general internet search and only found a few posts about holes in bags from cats' claws and such. It's weird that out of the thousands of ostomates using Coloplast products, only you are having this issue. If it was a more global problem with their bags, others would certainly be talking about it... but they're not. Not a peep. Not even one other person. And according to you, this has been going on for over a year now? Surely someone else would have said something. I'm not saying your problem isn't real... just not very prevalent with other Coloplast users. And without others having the same problem, Coloplast isn't going to make you a top priority... rather, they'll put you in the "don't call us... we'll call you" category and hope you just go away. And to be honest, if I were Coloplast, I'd do the same thing. Every company that sells products to consumers runs into some customers that are just never satisfied and a royal pain in the arse... and it's not worth their time or money to dump a lot of resources into fixing that one person's problems. I don't think you fall into that category because your issue is real... but it's cheaper to ignore just you than take action (and costs money) to fix a problem no one else seems to have.

So your options are limited. As I see it, you have three. First, find more people with the same problem to support your claims. That means posting on all the other ostomy sites to find others with the same problem. Once you have a group of people, you can present a stronger case to Coloplast to pay attention and fix the issue. And if you can't find anyone else having the problem, then you have to assume the problem is occurring AFTER the bags leave Coloplast and before they get to you. But at that point, Coloplast isn't liable anymore, and you need to find out who is.

Your second option is to post directly to Coloplast's online accounts, like I said earlier... i.e., Facebook, Instagram, and X. Call them out about your problem and see if anyone else chimes in. If folks do, then Coloplast will take you seriously. If not... you're the lone wolf again.

Third... you'll have to find another product to use. Whether that's a two-piece from Coloplast or a one-piece from someone else (I know you said you tried everything else out there... but probably not EVERY one)... or you'll have to find a way to "fix" the holes in your current Coloplast bags (Krazy Glue comes to mind). I mean... there just aren't many other options.

One thing I'm not sure you mentioned or not... are you finding holes in one or all bags in EVERY box of bags you get? Or are the holes in a random number of bags from each box (meaning some boxes of bags have NO holes)? Are the boxes sealed when you get them... either glued closed or with a sealing sticker over the box opening? Because if the boxes are sealed and you're claiming EVERY bag has holes... or at least one bag in every box has a hole... I'd make a video of you starting with a sealed box... show the lot number... open the box... find a bag with a hole... and show the camera. Check the other bags and show the camera every bag you find with a hole in it. Make sure the video is continuous and uncut and send it to both Coloplast and your insurance company. If the boxes you receive aren't sealed... well, then all bets are off.

Also, if you're claiming EVERY box has at least one bag with a hole in it... I'd buy a single box of the same product from another source (like Amazon or eBay). If you don't find a hole in one of those bags... you know someone is seriously messing with you. You haven't pissed off your mail carrier and UPS driver in the past year... have you?

To be continued...

;O)

AlexT
Jan 01, 2025 5:42 pm
Reply to w30bob

I swear someone else said basically the same thing. 🤔 

aTraveler
Jan 01, 2025 8:49 pm
Reply to w30bob

Most people never complain. I stopped using ConvaTec because of the poor adherence of their tape boundaries. A previous product had wider boundaries but this one had narrower boundaries that were not effective. I never complained and just tried other brands. This is how I handle every ostomy product I evaluate — I never notify the vendor, just evaluate an alternate product. I have seen many reports stating most people don't complain.

The second point I would like to make is Beth is using a 1-piece transparent appliance. This is an appliance that many of us were fitted with after ostomy surgery. Once we got home we moved to other appliances; namely, opaque and/or 2-piece.

So if you think about the large user-base for her appliance one thought quickly emerges. The users are newbies and if their was a hole in the pouch they would never know. Any leaks/smells would be attributed to not knowing how to manage the appliance. Even on this site when persons complained about smells the response has been about everything except check the pouch for holes. I have never checked a pouch for holes.

I would suspect these appliances have very low manufacturing costs. Typically the more expensive a product the more quality assurance is assigned to it.

I do believe Beth is finding manufacturing defects and I hope she can find a resolution.

aTraveler
Jan 01, 2025 8:52 pm
Reply to w30bob

That information is good to know. They are responsive to the FDA and the FDA actually will investigate consumer complaints.

aTraveler
Jan 01, 2025 8:59 pm
Reply to Beth22

Seems Coloplast is not registered with the FDA as they are continuing to grow their presence in the U.S.

They are responsive to the FDA and the FDA does investigate user complaints. If you don't get any response from the C.E.O., try contacting the FDA.

https://www.accessdata.fda.gov/scripts/medwatch/

 

w30bob
Jan 01, 2025 9:01 pm
Reply to AlexT

Hi Choo,

  It's the start of a new year...........don't swear!

😜

w30bob
Jan 01, 2025 9:25 pm
Reply to aTraveler

Hi a,

  I agree... but if I were finding holes in bags in every box I received, I'd sure complain. And if it was the only product that I could use because of problems with my skin when using other brands... I'd very much complain. Like you, I tend to overlook infrequent issues with products and just chalk it up to crappy quality control... but if I saw a post online about someone asking if I had a similar problem with the same product... I'd pipe up and reply. Remember, in this case, she can't use other brands... so she has no other option. I think anyone in that situation might be a bit more vocal about the problem. Most people have other options... and that makes all the difference.

  I was never fitted with a one-piece after my surgeries... but I hear ya. It's not clear why she can't use a two-piece, but that's pretty much irrelevant. I'm sure she has a good reason, and the one-piece shouldn't have pinholes. I'm not sure I'd assume only newbies use a transparent one-piece Coloplast product, but even if that were the case, I'd hope the ostomy nurses would notice the leaks were coming from outside the barrier, not under it... and either change brands or report the issue. The staining from a pinhole leak alone should give that away.

  We could go round and round about why her bags have pinholes, but the point is they shouldn't... whether they sell 1 box of those barriers a year or half a million. To be able to sell medical products in the States, the products have to be approved. As you mentioned, the FDA (under HHS) is responsible for regulating the safety and effectiveness of medical devices... effectiveness being the key word here.

  We all need to remember when most of us have an issue, we have other options... so it's really not that big of a deal. I've been where Beth is when I had no good options for getting my angry skin to behave and heal... and it's not fun when you don't have options. Maybe she can use a Coloplast 2-piece so it continues to agree with her skin... but maybe she can't. But if Coloplast can't make an ostomy product that performs as claimed, then that product should be removed from their lineup. Your suggestion about contacting the FDA is a good one! If they're like any other government organization, it's going to end up being a long drawn-out process, so resolution won't happen quickly. But it's definitely worth pursuing. But in the meantime, she needs a one-piece barrier/bag that doesn't leak and agrees with her skin.

;O)

Worzie
Jan 01, 2025 9:34 pm
Reply to aTraveler

I can see where you're going with the newbie thought.  IMHO, some of the holes she has shown would leave more than just an odor behind.  There wouldn't be any question about this defect being normal even for a new ostomate.

Testing out products for individual usability doesn't mean holes too.

Maried
Jan 01, 2025 9:35 pm
Reply to aTraveler

I have let the distributor know if there are defects in a bag and they send replacements. Ostomy bags are very expensive. Eighty bags damaged in a year's time and the replacements are damaged too, coming from Coloplast. If their defective rate is that high, Coloplast would/should most likely do a recall on the batches. There should also be tons of complaints from users. Bags are not optional and easily tossed like a defective box of straws.

aTraveler
Jan 01, 2025 11:51 pm
Reply to Maried

Marie, I guess I didn't make it clear, but companies make cost/benefit decisions. There was a major car manufacturer in the U.S. that was selling automobiles with a known defect that caused cars to catch fire. The determination was made that it was cheaper to pay out claims when they occurred than to perform an automobile recall. Although ostomy pouches are expensive, they all don't cost the same. I am sure one-piece transparent ostomy pouches are not any of the major companies' most expensive pouch. If you just look at the material cost, a one-piece is less expensive to manufacture than a two-piece. The SenSura Mio two-piece line is probably Coloplast's premier line or close to it. The company probably has larger profit margins on that line.

It is stated that, "Where are the others that are complaining?" — to that, I would say the company doesn't publish user complaints, therefore the question is more rhetorical since there is no way to answer it. There are close to a million people living in the USA with ostomies, with approximately 100,000 being performed each year. There is nowhere near that number of persons on ostomy sites, which means we are a tiny sample size to be basing defect decisions on. I certainly am in no position to assess the supplier chain involved in the delivery of the product to Beth.

With some of the holes, I saw, semi-formed stool would not seep through, but odor would. I have definitely had appliances where I smelled odor but couldn't detect a problem — I never checked for holes. When I was in the hospital, if a nurse saw a hole in a pouch, she would throw it out and apply another.

 

Maried
Jan 02, 2025 12:27 am
Reply to aTraveler

I would agree with you, but social media has come into the picture. Many people make their buying decisions based on reviews; bad reviews can really damage a company's business. When I was getting some bad service from a very large company—no callbacks, no customer service after 2 months of trying—I posted the issue/review on this site called Trust Pilot. Within 2 weeks, I was given a refund on my defective range.

Beth22
Jan 02, 2025 12:55 am
Reply to w30bob

Hey Bob,

Yes, literally every single bag has a hole. Depending on where the holes are and how big they are, I will try to patch them. But yes, every bag—I am not going to get frustrated or complain if it is one here or there. But when it's all the bags and for well over a year, that's frustrating, and yes, the replacements they send out will have holes too. As soon as my bags arrive, I get them straight from UPS or FedEx. I make sure everything is accounted for in my order, and I go through my products to make sure nothing else is damaged. Yes, everything is sealed, and the box the bags come in isn't messed up or anything else. And yes, they have gotten pictures, and yes, I have tried other bags from Coloplast, as I have said I don't know how many times above. And I will say again, it doesn't matter which location the bags come from; there are holes, and when Coloplast sends replacements, it doesn't go through where your distribution company sends from; it comes from Coloplast's warehouse. They have tried other locations. It's during the manufacturing process, just like when I had an entire bag ripped completely open, and they sent it to me, and as I had posted a million other times, drag markers and other weird issues. And I even went to try their older line—holes in the bag, the flip had holes, I can't wear a 2-piece for many reasons that I don't need to explain for one, and for two, that's not the point. I should be able to wear what works for me and not have an issue. And yes, I literally have tried every bag on the market. I am allergic to them. I even went as far as contacting bag manufacturers overseas, and in Canada, asking if they would send to the USA. They said no, not once, not twice, but three times. I have tried the silicone that burnt the crap out of my skin. But I shouldn't, and I am not going to sit and explain myself anymore, as everything has been posted above, and this post isn't going directly to you, so I am not singling you out. You have been trying to be helpful, and I appreciate that. This part is going to the entire thread. What's horrible is it seems literally everyone on this thread is coming at me in a non-helpful way. I don't care if none of you believe what I am going through; that's not why I posted to begin with. And let's just hope and pray you don't have to be in a situation the way I have been, and then to have what's supposed to be the one place since we all have ostomies that would understand, be rude and say how unbelievable it is. Seriously, nice community of uplifting people. Which is why I don't post threads myself, and I only post on others when I have literally walked in the shoes they are walking in to try and help. I posted it so others could be aware and check their own bags for their sake, a heads-up, and to help someone else out. And Bob, I know they won't take it seriously; they haven't and won't. I get it, but it isn't going to stop me from trying to get it fixed, and I know they don't call back, but I sure as heck will. This to me isn't a damn game; this is my livelihood, and I have been patient as all get out when it comes to them. They have gotten their millions of pictures; it's all documented, and all the pictures from a year in are in their case files, and they pull them up, and they get more, and they also get the bags shipped right back to them. And I have tried buying from other places, and the same thing happens. Holes. Holes and more holes. Oh wait, and more holes.

Beth22
Jan 02, 2025 1:04 am
Reply to w30bob

Thank you, Bob, for understanding. I have tried hard to switch, but unfortunately, it isn't an option. Trust me, I wish it was; I would have left a long time ago. Thank you for understanding why, because I am allergic to everything, which makes this issue tough since it is my only option, which sucks. I haven't complained for over an entire year about this. Actually, I don't even hardly create a thread about anything, and I'm not complaining now, just putting it out there to help others if they have issues and to give a heads up. I'm not sure when that became complaining. And actually, I was in a two-piece after 5 ostomy surgeries in a year and being cut open 2 times less than 3 months apart, and where my 6th stoma ended up, a two-piece is not an option anymore.

Beth22
Jan 02, 2025 1:59 am
Reply to Maried

Oh no, it's well over 80 bags in a year. I said I have 80 right now just from last month that have holes, including the replacements they sent.

Beth22
Jan 02, 2025 2:04 am
Reply to Maried

Just because people have social media doesn't mean they put everything out there, so no, we don't know how many people are having this issue. I don't put my stuff on social media, and I didn't say anything about holes until well over a year later. Not everyone puts stuff on the internet.

Beth22
Jan 02, 2025 2:07 am
Reply to aTraveler

A traveler, thank you very much. You have been the only one that has not sat and questioned me to death, or come against me. Thank you again, so very much. It is very appreciated.

aTraveler
Jan 02, 2025 6:46 am
Reply to Beth22

Beth, I admire your tenacity. It takes a lot of internal strength and resolve when others imply you are the problem. As you have observed you can continue ad infinitum addressing assertions others make in defense of the manufacturer — no answer you give will be suitable. My grandmother used to always admonish me that "you can't argue with a sign post." Beth, I hope you do as Jim Valvano pledged, “Don’t give up. Don’t ever give up.”

Finally remember this:

"All that was great in the past was ridiculed, condemned, combated, suppressed — only to emerge all the more powerfully, all the more triumphantly from the struggle."
  — Nikola Tesla.

Beth22
Jan 02, 2025 3:35 pm
Reply to aTraveler

A traveler, thank you, and that poem is beautiful. I have never read that before. Thank you for writing it to me. And don't worry, I don't think it's in my nature to give up. This is not the first time I have been pushed up against a wall and mocked... I also had doctors do it for almost 20 years. Boy, do they look stupid now, lol. But again, thank you. Your kind words and support are wonderful and so appreciated.

w30bob
Jan 02, 2025 9:16 pm
Reply to Beth22

Hi B,

  I have an idea. Let me know exactly which one-piece barrier bag you use... and I'm going to order a box online. When they get here, I'm going to open the box and inspect each one for pinholes. Either way, we'll learn something. If they have the holes like yours do, it's squarely Coloplast's problem. If they don't have the holes, it means something else is amiss, and they're probably off the hook, and we can focus on what happens after their product leaves their warehouses. Also, if they have the holes, I'll contact Coloplast and see what they tell me... which should be interesting in its own right. No holes, and I'll send the box to you so you can have some 'unholy' ones to use while we get to the bottom of this. 

;O)

 

Beth22
Jan 03, 2025 12:10 am
Reply to w30bob

No, and I'm not playing this game. Seriously, I have no idea what in the world is wrong with everyone besides atraveler. I know it's Coloplast's problem; it has been for over a year. And this is supposed to be part of a community that is supposed to be supporting? I don't see any of that here. Y'all want to sit and question and pretty much say I am a liar. Nah, I'm good. As I said before, I don't care who does and doesn't believe me. I am going through it and have been. I'm not going to sit and play games so you can see for yourself if I'm lying or not. And I am not going to reply anymore as everything has been said over 5 different times.

Atraveler, thank you for being literally the only truly nice and supportive one.

w30bob
Jan 03, 2025 3:26 am
Reply to Beth22

B.........you totally missed the point.  But as you say........we're done.  Good luck!

;O)