MAUDE Adverse Event Report: COVATEC CLOSED END POUCH

Model Number 413144

Device Problem Leak/Splash (1354)

Patient Problem Unspecified Infection (1930)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

Convatec active life one piece closed end pouch, ref 413144, lot 4g00671 leak in pouch leading to material leaking and giving me bladder infection.

• Brand Name: CLOSED END POUCH
• Type of Device: CLOSED END POUCH
• Manufacturer (Section D): COVATEC
• MDR Report Key: 5250148
• MDR Text Key: 32212968
• Report Number: MW5058126
• Device Sequence Number: 1
• Product Code: EZQ
• 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: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2016
• Device Model Number: 413144
• Device Lot Number: 4G00671
• Other Device ID Number: 6845510605
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 95