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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 Problem Material Disintegration (1177)
Patient Problem No Patient Involvement (2645)
Event Date 07/31/2020
Event Type  malfunction  
Event Description
It was reported that the silicone going off the foam pad and stays on the back cover when removed.No case involved.
 
Manufacturer Narrative
We have now concluded our investigation for the complaint received.The devices were intended for use in treatment.The returned dressings were visually and functionally evaluated which confirmed the issue of silicone offsetting.This confirmed a relationship between the event and the device.With the root cause identified as a raw material issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.However, this investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.
 
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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 Key10550782
MDR Text Key207491023
Report Number8043484-2020-02898
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 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800270
Device Lot Number201848
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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