MAUDE Adverse Event Report: CONVATEC, PURCHASING DEPARTMENT ESTEEM PLUS ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Catalog Number 416718

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 02/02/2019

Event Type  malfunction  

Event Description

Multiple colostomy bags found to have adhesive that does not stick.The part of the device that is supposed to be sticky is not sticky or tacky at all.It is immediately apparent that something is wrong with the product.We have notified the manufacturer and are returning multiple boxes.Multiple lots are affected.Lot 8b00773, 8k01707, 8g01414, 8j01719, 8k04961, 8g01414.

• Brand Name: ESTEEM PLUS ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, PURCHASING DEPARTMENT; 1160 route 22 east centerpointe ii; bridgewater NJ 08807
• MDR Report Key: 8503218
• MDR Text Key: 141591007
• Report Number: 8503218
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 416718
• Device Lot Number: 8B00773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2019
• Date Report to Manufacturer: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA