MAUDE Adverse Event Report: COLOPLAST (CHINA) LTD. DEEP CONVEX UROSTOMY POUCH; COLLECTOR, OSTOMY

Model Number 16870

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

While using a new lot of urostomy bags lot number 7525646, i had three urostomy bag failures in four days.The previous lots i have had no issues.The expiration date for this lot is 13 may 2022.I have also contacted the company that manufactured the urostomy bags which is (b)(4).Fda safety report id # (b)(4).

• Brand Name: DEEP CONVEX UROSTOMY POUCH
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): COLOPLAST (CHINA) LTD.
• MDR Report Key: 12569617
• MDR Text Key: 274817624
• Report Number: MW5104362
• Device Sequence Number: 2
• Product Code: EXB
• 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: 09/30/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 16870
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 93