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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 421622
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Laceration(s) (1946); Tissue Damage (2104); Ulcer (2274); Blood Loss (2597)
Event Date 03/05/2020
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury. 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 reported that her stoma fluctuates at the proximal end, and it sometimes gets larger than 25mm and as a result, the convex piece of the appliance rubbed her stoma. It resulted in what appeared to be an ulceration and lacerated her stoma measuring 2mm. She stated that this area, which was at 3 o'clock spot on her stoma, did bleed a small amount but resolved after applying pressure for a few seconds. She noted this area within a few hours of application and removed the appliance and went back to her convex 2-piece appliance. After a couple of days, she developed an "exacerbation" of crohn¿s, which manifested 1-2mm ulcerations to the stoma that comes and goes. When she changed the appliance on (b)(6) 2020, seven ulcerations were noted. Reportedly, her stoma was "inflammed" and enlarged in size. Thereafter, she switched to a durahesive product with a larger wafer stoma opening. She is a nurse practitioner and was caring herself for the stoma at home. She denied hernia or bulge. Her doctor did not want to see her due to the covid issues. She was not using any prescription items on her stoma. Her stoma becomes mushroom shaped when it does fluctuate. 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
pamela meadows
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key10054605
MDR Text Key196981808
Report Number1049092-2020-00126
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,health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2022
Device Model Number421622
Device Lot Number0000034736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received05/04/2020
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

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