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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 Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2015
Event Type  malfunction  
Event Description
It was reported the sterile packaging for the drain-fix dressing was torn upon delivery.No pt involvement was reported.
 
Manufacturer Narrative
Based on the available info, this event is deemed a reportable malfunction.Additional event details have been requested.Should additional info become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2015.
 
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Brand Name
DRAIN-FIX SMALL
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
CONVATEC LIMITED
unit 20, first avenue
deeside industrial park
deeside, flintshire CH5 2NU
UK  CH5 2NU
Manufacturer Contact
matthew walenciak, int asso dir
211 america avenue
greensboro, NC 27409
9083779293
MDR Report Key4701873
MDR Text Key5720688
Report Number1000317571-2015-00025
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,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/01/2018
Device Model Number417107
Device Lot Number5A02077
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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