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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED DRAIN-FIX SMALL; TAPE AND BANDAGE, ADHESIVE
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CONVATEC LIMITED DRAIN-FIX SMALL; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Model Number 417107
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Customer has complained of two instances where oil stains on peelable pouches and are concerned this will affect product performance.
 
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Brand Name
DRAIN-FIX SMALL
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
CONVATEC LIMITED
first ave
deeside industrial park
deeside, flintshire CH52N U
UK  CH52NU
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5203991
MDR Text Key30469757
Report Number1000317571-2015-31399
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date02/01/2014
Device Model Number417107
Device Lot Number1B03656
Was Device Available for Evaluation? No
Date Manufacturer Received02/27/2014
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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