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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC VARIHESIVE XTHIN SURGICAL9X35CM; DRESSING,WOUND,OCCLUSIVE
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CONVATEC VARIHESIVE XTHIN SURGICAL9X35CM; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187922
Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2013
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
It was reported that the dressing is not sticking to the wound when the patient leaves the hospital.
 
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Brand Name
VARIHESIVE XTHIN SURGICAL9X35CM
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
CONVATEC
211 american ave
greensboro NC 27409
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5124457
MDR Text Key27366866
Report Number1049092-2015-30198
Device Sequence Number1
Product Code NAD
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 foreign,user facility
Reporter Occupation Other
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 No Information
Device Expiration Date01/31/2018
Device Model Number187922
Device Lot Number3A02133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2013
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2013
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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