MAUDE Adverse Event Report: ESTEEM+ FLEX CONVEX

Model Number 421619

Device Problem Product Quality Problem (1506)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Common device name: pouch, colostomy.Based on the available information, this event is deemed a reportable malfunction.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.

Event Description

The end user reported that the ¿outer edge of hydrocolloid barrier seemed sharp and felt like it was digging into the skin." she went on to report that these edges felt sharp as soon as she applied the pouch.She applied tape to cover the outer areas and it helped a little but, she removed the pouch after one day wear due to being uncomfortable.There was no irritation or skin injury noted when she removed the pouch.It was further reported that she had discomfort but, no actual harm reported.

Manufacturer Narrative

A batch record review indicates no discrepancies.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.Fda registration number: (b)(4).

• Brand Name: ESTEEM+ FLEX CONVEX
• MDR Report Key: 7363098
• MDR Text Key: 103541888
• Report Number: 1049092-2018-00117
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 421619
• Device Lot Number: 1708033325737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR