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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC ESTEEM POUCH, COLOSTOMY

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CONVATEC ESTEEM POUCH, COLOSTOMY Back to Search Results
Model Number 416718
Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2019
Event Type  malfunction  
Event Description
Multiple colostomy bags from multiple lots found to have adhesive that does not stick. The lack of adhesive cannot be detected until the device is opened. Multiple devices within each lot are affected. The numbers of each lot are listed here. The devices cannot be used and a new one must be opened until one that has working adhesive is found. The bags that have non-working non-sticking adhesive have been discarded. It is as if the bags were manufactured without any of the sticky adhesive having been applied to them. There is not a way for the customer to know this until the packaging is opened and the customer tries to apply the device--it slips off and does not stick at all. There is absolutely no adhesion or stickiness. Affected lots are 8b00773, 8k01707, 8g01414, 8j01719, 8k04961, 8g01414.
 
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Brand NameESTEEM
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC
7900 triad center drive, suite 400
greensboro NC 27409
MDR Report Key8861516
MDR Text Key153340489
Report Number8861516
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 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416718
Device Catalogue Number416718
Device Lot Number8B00773
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 FDA07/16/2019
Event Location No Information
Date Report to Manufacturer08/05/2019
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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