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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC DUODERM XTHIN DRS 12.5X12.5CM; DRESSING,WOUND,OCCLUSIVE
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CONVATEC, INC DUODERM XTHIN DRS 12.5X12.5CM; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 420061
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2014
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.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
The health care professional reported that the edges of the duoderm dressing roll.
 
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Brand Name
DUODERM XTHIN DRS 12.5X12.5CM
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 Key5113373
MDR Text Key27103736
Report Number1049092-2015-30262
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
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 Health Professional
Device Model Number420061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/30/2015
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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