MAUDE Adverse Event Report: CONVATEC INC ESTEEM+ FLEX CONVEX

Model Number 421622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Common device name - pouch, colostomy.Complainant was unable to provide the product lot number.Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Although a photograph (s) has been received, no evaluation will be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the end user states ¿she feels may have had a urinary tract infection (uti) as a "result of the pouch tail that she was not able to clean adequately." the uti contained e-coli when tested.Uti was treated with antibiotics (no name was provided).The uti was not confirmed to be related to the pouch, which was a sample pouch the end user was trying.End user states she had difficulty cleaning the pouch "as it had to roll up a couple of times, then was fastened shut.There could have been feces that i couldn't see on the tail of the bag or velcro." end user reports she is better now.No further information was provided.

• Brand Name: ESTEEM+ FLEX CONVEX
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8017446
• MDR Text Key: 125423905
• Report Number: 1049092-2018-00589
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421622
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57