MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1-PIECE UROSTOMY POUCH PRECUT 5/8" WITH DURAHESIVE BARRIER; BAG, URINARY, ILEOSTOMY

Model Number 125362

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I have worn a urostomy pouch for the last 50+ years; for the last 15 years, i have worn convatec activelife 1-piece urostomy precut 5/8" pouches.For the past 2 years, i have had repeated problems with pouch leaks due to product failure.What began as something that occurred with 1 in 10 pouches is now happening at the rate of 3 out of 4 pouches.I am currently using pouches from a box of ten; of the first four, three have failed.The pouches stay on without leakage for an average of 24 hours.Historically, pouches would not require changing for 7 to 10 days.Over the last 2 years, product failure has occurred variously (failure at the edge seam; pinpoint holes in the bag surface; or most commonly, at the point where the baseplate meets the flange).The most recent series of pouch failures (over the past 3 months) have been in the area of the baseplate/flange.I have contacted both the product distributor and the manufacturer about this issue.Both have provided me with replacement products: i have experienced identical failures in the replacement products.It has been suggested that the issue may be my improper application of the product, but given that i have been using the same pouch for the last 15 years (without issue until recently) and the fact the product failure does not occur at the stoma site (i.E., suggesting leakage due to prolonged wearing or improper application) but rather at the mechanical point where flange meets baseplate, i am certain that the failure is due to the product.Reference reports: mw5147072, mw5147074.

• Brand Name: ACTIVELIFE 1-PIECE UROSTOMY POUCH PRECUT 5/8" WITH DURAHESIVE BARRIER
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.
• MDR Report Key: 17964693
• MDR Text Key: 326356697
• Report Number: MW5147073
• Device Sequence Number: 1
• Product Code: EXH
• 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: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: 125362
• Device Lot Number: 2K02257
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG