MAUDE Adverse Event Report: CONVATEC SUR-FIT NATURA POUCH

Lot Number H01019

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Pt's ostomy pouch has come apart on two occasions at the ring.Pt wants the mfr to put a warning on the package for users to tug on the pouch before using it.Pt will like to know the failure rate of these pouches.Also wants to know what steps the manufacturer is taking to amend this problem.

• Brand Name: SUR-FIT NATURA POUCH
• Type of Device: SUR-FIT
• Manufacturer (Section D): CONVATEC
• MDR Report Key: 4192856
• MDR Text Key: 20752329
• Report Number: MW5038708
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: H01019
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 61