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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10 X 10CM CTN 10; DRESSING,WOUND,OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10 X 10CM CTN 10; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800270
Device Problems Loss of or Failure to Bond (1068); Material Disintegration (1177)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2020
Event Type  malfunction  
Event Description
It was reported that during set up the silicone detached from the dressing.No patient involved.
 
Manufacturer Narrative
The device, intended for use in treatment, has been received for evaluation.A visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed that the dressing had reduced bonding capabilities, establishing a relationship with the reported event.The root cause has been identified as a raw material issue.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.The complaint history review found further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
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Brand Name
ALLEVYN GENTLE BORDER 10 X 10CM CTN 10
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key10525037
MDR Text Key206649168
Report Number8043484-2020-02846
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800270
Device Lot Number201951
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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