MAUDE Adverse Event Report: CONVATEC, PURCHASING DEPARTMENT ESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE; POUCH, COLOSTOMY

Model Number 416718

Device Problem Material Integrity Problem (2978)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

Colostomy bags found with sub-optimal adhesive.

• Brand Name: ESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, PURCHASING DEPARTMENT; 7900 triad center drive; suite 400; greensboro NC 27409
• MDR Report Key: 8959632
• MDR Text Key: 156438777
• Report Number: 8959632
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 416718
• Device Catalogue Number: 416718
• Device Lot Number: 9A02271
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1