MAUDE Adverse Event Report: CONVATEC INC ESTEEM + FLEX CONVEX; POUCH, COLOSTOMY

Model Number 422363

Device Problem Sharp Edges (4013)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot 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

The end user experienced skin irritation near stoma, which he believed was because he had a "jagged edge" of opening after he had cut it to 45 mm.Reportedly, he had previous skin irritation but he believed that this product was causing additional skin irritation.He continued to use the product and did not require medical attention.His skin care included unknown brand adhesive remover and then baby wipes.No photo is available at this time.

• Brand Name: ESTEEM + FLEX CONVEX
• Type of Device: POUCH, COLOSTOMY
• 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 ; 3365424681
• MDR Report Key: 10348489
• MDR Text Key: 204627493
• Report Number: 1049092-2020-00161
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 422363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33