MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+ I

Model Number 421626

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 5 of 7. Common device name: pouch, colostomy. Contact office address: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. 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's wife reported that the edge of the opening was rough instead of smooth in 7 out of 10 appliances. The product was not used on patient. Photograph depicting the issue was received from the complainant.

• Brand Name: L3O0675 - ESTEEM+
• Type of Device: I
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 12365047
• MDR Text Key: 268049649
• Report Number: 1049092-2021-00088
• 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: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 421626
• Device Lot Number: 0000252523
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown