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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, PURCHASING DEPARTMENT ESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE POUCH, COLOSTOMY

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CONVATEC, PURCHASING DEPARTMENT ESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE POUCH, COLOSTOMY Back to Search Results
Model Number 416718
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2019
Event Type  malfunction  
Event Description
Colostomy bags found with sub-optimal adhesive.
 
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Brand NameESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC, PURCHASING DEPARTMENT
7900 triad center drive
suite 400
greensboro NC 27409
MDR Report Key8959632
MDR Text Key156438777
Report Number8959632
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416718
Device Catalogue Number416718
Device Lot Number9A02271
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Event Location No Information
Date Report to Manufacturer09/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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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