MAUDE Adverse Event Report: CONVATEC ESTEEM; POUCH, COLOSTOMY

Model Number 416718

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)

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

Event Date 02/02/2019

Event Type  malfunction  

Event Description

Multiple colostomy bags from multiple lots found to have adhesive that does not stick.The lack of adhesive cannot be detected until the device is opened.Multiple devices within each lot are affected.The numbers of each lot are listed here.The devices cannot be used and a new one must be opened until one that has working adhesive is found.The bags that have non-working non-sticking adhesive have been discarded.It is as if the bags were manufactured without any of the sticky adhesive having been applied to them.There is not a way for the customer to know this until the packaging is opened and the customer tries to apply the device--it slips off and does not stick at all.There is absolutely no adhesion or stickiness.Affected lots are 8b00773, 8k01707, 8g01414, 8j01719, 8k04961, 8g01414.

• Brand Name: ESTEEM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC; 7900 triad center drive, suite 400; greensboro NC 27409
• MDR Report Key: 8861516
• MDR Text Key: 153340489
• Report Number: 8861516
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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: 8B00773
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Date Report to Manufacturer: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1