Decline in Convatec's Products and Service

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steiconi
Posts: 1051
Joined: 2015-05-18 03:12:03

Re: Decline in Convatec's Products and Service

Post by steiconi »

Not life threatening, but my last two pouches have had issues. One had a tiny leak next to the ring, the other came untuppered from the wafer.
Geeze
Lee

I am not my disease.
sabresfan18
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Joined: 2022-04-18 17:20:47

Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

steiconi wrote: 2022-06-22 23:40:00 Not life threatening, but my last two pouches have had issues. One had a tiny leak next to the ring, the other came untuppered from the wafer.
Geeze

Sorry to hear you're having issues.

Thing is, none of these issues are "life-threatening" right? But we, as consumers, need to hold Convatec to a higher standard. I have done that by transitioning my supplies to another company.

They need to get their quality control issues under control.
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

Here's an article I found from last month that gives some insight as to what's going on at Convatec from a financial standpoint. Them cutting corners when it comes to quality control makes sense, but it doesn't make it acceptable.

https://www.yahoo.com/video/three-decli ... 42317.html
NEskier
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Re: Decline in Convatec's Products and Service

Post by NEskier »

Thing is, none of these issues are "life-threatening" right? But we, as consumers, need to hold Convatec to a higher standard. I have done that by transitioning my supplies to another company.

They need to get their quality control issues under control.
Just out of curiosity, what brand did you switch to? I have used the same products from Convatec since 1984. The furthest 'experiment' I ever had was trying Durahesive (hated it) vs Stomahesive flanges.
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Mara
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Re: Decline in Convatec's Products and Service

Post by Mara »

Ditto to what NEskier said - I am still satisfied with my Convatec products that I also have used for decades. I never even tried the Durahesive....lol...my theory is why mess with success or near success.

Whenever I have had an issue I call Convatec and get a replacement box. My pouches (401934) in a recent order were all wrinkled up for some odd reason - never saw that before. Called Convatec and got a new box...case closed....
Ileostomy due to UC - 50 odd years
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

NEskier wrote: 2022-06-23 13:07:06
Thing is, none of these issues are "life-threatening" right? But we, as consumers, need to hold Convatec to a higher standard. I have done that by transitioning my supplies to another company.

They need to get their quality control issues under control.
Just out of curiosity, what brand did you switch to? I have used the same products from Convatec since 1984. The furthest 'experiment' I ever had was trying Durahesive (hated it) vs Stomahesive flanges.
I switched to Coloplast. Is it perfect? No. Am I getting better with the supplies and adapting? Absofreakinglutely. And the pouches are leaps and bounds better than Convatec's new line.

Coloplast will send you samples for free -- of both the flanges and the pouches. And trust me, they send you enough to mess around with and have some failed changes.

I would highly recommend reaching out to Coloplast or Hollister and seeing what might be available to you. Both companies are extremely generous with samples.

Also, my DM's are open should you have any questions or concerns.
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

Mara wrote: 2022-06-23 13:14:29 Ditto to what NEskier said - I am still satisfied with my Convatec products that I also have used for decades. I never even tried the Durahesive....lol...my theory is why mess with success or near success.

Whenever I have had an issue I call Convatec and get a replacement box. My pouches (401934) in a recent order were all wrinkled up for some odd reason - never saw that before. Called Convatec and got a new box...case closed....
Mara, respectfully, I think a big part of the reason you're still satisfied with Convatec is the fact that the pouches you utilize were NOT a part of this re-design by Convatec. Thus the product you've used for a significant amount of time remains unimpacted. This is compared to many of us who are having actual adverse physical (and social) dilemmas due to the changes Convatec implemented to our products.

I am not trying to get anyone to change from Convatec if it's working for you. I think you should utilize what products make you the most confident and comfortable. I'm trying to provide outlets to customers that WERE impacted by this re-design and didn't experience an open-and-shut case like the only one you describe with your supplies.

Thanks.
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

sabresfan18 wrote: 2022-06-22 14:44:18
Mara wrote: 2022-06-21 22:24:59 As far as reporting to the FDA, I am not sure exactly what the point is. Ostomy appliances are Class 1 Medical Devices which do not need much in the way of regulatory approvals as far as I understand.
Here is an article that explains FDA classifications:
https://www.fda.gov/medical-devices/con ... -marketing

I still recall a poster from a long ago, previous iteration of this discussion board - maybe Bob Webtech remembers - who often complained that the FDA didn't control ostomy appliances.

Based on the conversation I had with a pharmacist that works at Medwatch, that's not necessarily true. If the product is determined to be causing physical adverse effects, it can be re-reviewed with these concerns in mind.

You could be right, I could be right. Either way, I encourage folks to file reports if they feel Convatec's products have adversely impacted them.

The more information the FDA receives regarding the company, the more inclined they're going to be to see what's going on.
Further update for those interested: a representative from the FDA reached out to me this morning requesting clinical notes from my Ostomy NP to open an investigation into the pouch line. The FDA DOES have the ability to recall a product if it's deemed the quality does not meet standards or the product is causing adverse physical reactions to patients.

I (again) highly encourage anyone who's been negatively impacted by Convatec's new line of pouches to file a report at the hyperlink below:

https://www.fda.gov/medical-devices/rep ... nduct-form
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Mara
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Re: Decline in Convatec's Products and Service

Post by Mara »

Glad you are making progress in your complaint, sabresfan18! What do they mean by 'clinical notes from my Ostomy NP'? If I were having issues with my pouches, does that mean I have to go to a WOCN for paperwork?? That's an issue particularly in these Covid days.....I have always dealt with issues on my own....don't have a WOCN....
Ileostomy due to UC - 50 odd years
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

Mara wrote: 2022-06-29 14:52:35 Glad you are making progress in your complaint, sabresfan18! What do they mean by 'clinical notes from my Ostomy NP'? If I were having issues with my pouches, does that mean I have to go to a WOCN for paperwork?? That's an issue particularly in these Covid days.....I have always dealt with issues on my own....don't have a WOCN....
Mara,

I sought care from a WOCN because of the hypergranulation that was resulting from Convatec's newly designed bags. Her fitting me with another product is just an additional service that she (and most other WOCNs) offer.

Appreciate your kind words and well wishes. Nothing wrong with handling things on your own -- I did it for 22 years. But Convatec's pouch changes significantly changed my ability to perform my ADLs, so I sought professional help.
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Mara
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Re: Decline in Convatec's Products and Service

Post by Mara »

I just wondering if someone can complain if they have not sought the help of a medical professional....like I say I have no problems now but who knows....
Ileostomy due to UC - 50 odd years
sabresfan18
Posts: 34
Joined: 2022-04-18 17:20:47

Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

Mara wrote: 2022-06-29 17:58:15 I just wondering if someone can complain if they have not sought the help of a medical professional....like I say I have no problems now but who knows....
Yes, you can make a complaint without having seen a provider regarding it. Clinical notes were not a required aspect of the investigation but because I indicated that I sought medical attention for the adverse reaction the device caused me, the FDA investigator reached out and asked if I'd be willing to share pertinent clinical notes. However, she stated this was not required for them to continue to pursue the investigation.

Obviously, I think it goes without saying if you're claiming something caused you an adverse physical reaction, it's reasonable to expect to provide clinical proof of that. I had my last 6 months of chart notes saved as a PDF on my school laptop, so I was able to provide her with this information within minutes (God bless patient portals).
ileo73
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Re: Decline in Convatec's Products and Service

Post by ileo73 »

May be a digression but:

I also had granulation tissue from Convatec but that was the hard plastic ring of the Tupperware connection. Cleared up once I found a one piece I could use

In the meantime, I found hydrofera blue was almost a magic bullet on granulation tissue. It needs a piece of brava sheet or something else to hold it on, but it kept me from needing to go to have the granulation cauterized each time
sabresfan18
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Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

ileo73 wrote: 2022-07-06 09:22:04 May be a digression but:

I also had granulation tissue from Convatec but that was the hard plastic ring of the Tupperware connection. Cleared up once I found a one piece I could use

In the meantime, I found hydrofera blue was almost a magic bullet on granulation tissue. It needs a piece of brava sheet or something else to hold it on, but it kept me from needing to go to have the granulation cauterized each time
Hi there, thanks for your feedback.

Granulation will result after extended periods of pressure and/or moisture build-up. While your adverse reaction is likely unrelated to Convatec's re-design of their pouches, it's still a concern. Ostomy patients will press on two-piece seals to ensure they're on, and Convatec shouldn't expect their consumers to switch to one-piece systems to avoid it.

Regardless, I am glad you found something that works for you. And thanks again for your input.
sabresfan18
Posts: 34
Joined: 2022-04-18 17:20:47

Re: Decline in Convatec's Products and Service

Post by sabresfan18 »

Quick update for anyone interested:

Bruno, the new COO of their Ostomy division, has asked to meet with me again on August 29th. They explained that there are a lot of scheduling conflicts for them currently, hence the meeting being dated out so far.

Thanks.
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