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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESTEEM+ FLEX CONVEX

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ESTEEM+ FLEX CONVEX Back to Search Results
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).
 
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Brand NameESTEEM+ FLEX CONVEX
MDR Report Key7363098
MDR Text Key103541888
Report Number1049092-2018-00117
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2020
Device Model Number421619
Device Lot Number1708033325737
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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