MAUDE Adverse Event Report: CONVATEC, INC. NATURA CLOSED POUCH; POUCH, COLOSTOMY

Model Number 421681

Device Problems Product Quality Problem (1506); Gas/Air Leak (2946); Noise, Audible (3273)

Patient Problems Emotional Changes (1831); Granuloma (1876); Pain (1994)

Event Date 09/01/2021

Event Type  Injury  

Event Description

Convatec has supplied my colostomy and urostomy supplies for almost 26 years.My colostomy was installed in 1999 when i was in 6th grade; my urostomy was installed in 2004 when i was in 9th grade.In (b)(6) of 2021, convatec redesigned its ostomy pouch line.The new line features a new liner that is causing patients to sweat, causing sweat to collect under flanges.When this occurs, hypergranulation often results and requires cauterization to heal.This procedure is both expensive and painful.Convatec has also created a second-hand market for the old bags (that they discontinued), as you'll find them on websites being sold for almost twice their original value.In addition to this, convatec is charging more for the new line of pouches, even though they're made with lesser quality materials.In addition to the hypergranulation concerns, the pouches are noisy and impact my social confidence.They also leak smells more frequently than the old ones, affecting my confidence and ability to perform social activities.I have spoken with convatec's coo ((b)(6)) and director of r&d.While i think they have good intentions to turn things around, i feel it's worthwhile for the fda to investigate convatec's transition to this new line of pouches and if they actually meet for approval.I would ask that convatec's new line of pouches be re-evaluated for approval as i do not feel the issues i've had are significant and warrant reconsideration.I have found myself buying the old (discontinued bags) on the secondhand market, and as a graduate student who works full time, it is financially stressing me.I can't help but think convatec can do better in offering a better product, and i hope that the fda can help me navigate this as it's significantly impacting me socially, emotionally, and physically.I've tried every other competitor's products; nothing works as well as convatec.I am reading on ostomy websites that other convatec users are buying the old pouches (ref# (b)(4)) on the second-hand market and then washing them out and re-using them.This is a massive infection risk and a testament that there's still a demand for the old product because the newly approved line of pouches is not meeting other ostomy patient needs.The reference number of the old (excellent quality) pouches i used was (b)(4).In (b)(6) of 2021, these pouches were replaced with the (lesser quality) pouches with reference number (b)(4).I have included photos for your reference -- there are two: one of the outside of the bag, and i also include one of the bags turned inside out so you can see the difference in products.Here is a link to the thread i started on the uoaa (united ostomy association of america) regarding convatec's recent changes.You can see i'm not the only one struggling with their decision to shrink lot size to streamline their process and offer a lesser quality product.Thanks for your time and help in advance.Fda safety report id# (b)(4).

• Brand Name: NATURA CLOSED POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.
• MDR Report Key: 14436654
• MDR Text Key: 292221572
• Report Number: MW5109782
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 421681
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Race: White