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U.S. Department of Health and Human Services

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

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CONVATEC INC ESTEEM + FLEX CONVEX POUCH, COLOSTOMY Back to Search Results
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.
 
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Brand NameESTEEM + FLEX CONVEX
Type of DevicePOUCH, 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 Key10348489
MDR Text Key204627493
Report Number1049092-2020-00161
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number422363
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 Received07/08/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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