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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM PCH CLD SM TAN 20MM (1X30PK); POUCH, COLOSTOMY
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CONVATEC LIMITED ESTEEM PCH CLD SM TAN 20MM (1X30PK); POUCH, COLOSTOMY Back to Search Results
Model Number 404657
Device Problems Material Disintegration (1177); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2016
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
End user reports that after less then 2 days, the adhesive around the stoma is breaking down and getting "sucked into stoma causing a plug effect.".
 
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Brand Name
ESTEEM PCH CLD SM TAN 20MM (1X30PK)
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC LIMITED
first avenue
deeside industrial park
deeside, flintshire CH52N U
UK  CH52NU
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5739612
MDR Text Key47895894
Report Number1000317571-2016-00052
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number404657
Was Device Available for Evaluation? No
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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