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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC DUODERM XTHIN DRS 10X10CM; DRESSING,WOUND,OCCLUSIVE
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CONVATEC, INC DUODERM XTHIN DRS 10X10CM; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187955
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2014
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation (b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
The end-user's spouse reported that 3 duoderm dressings out of box of 10 have edges that were not adhering in less than 24 hours of wear.
 
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Brand Name
DUODERM XTHIN DRS 10X10CM
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
CONVATEC, INC
211 american ave
greensboro 27409
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5113275
MDR Text Key27099858
Report Number1049092-2015-30254
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2018
Device Model Number187955
Device Lot Number3K02202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
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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