MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE® CONVEX ONE-PIECE POUCH; POUCH, COLOSTOMY

Model Number 175780

Device Problem Difficult to Remove (1528)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported that after two (2) days of use, the device was difficult to remove and once removed caused bleeding to the skin underneath the mass.The patient was using stomahesive powder and barrier wipes on the bleeding areas.

• Brand Name: ACTIVELIFE® CONVEX ONE-PIECE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5518205
• MDR Text Key: 40932837
• Report Number: 1049092-2016-00101
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 YR