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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 Integrity Problem (2978)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2020
Event Type  malfunction  
Event Description
It was reported that the silicone goes off the foam pad and stays on the back cover when removed.
 
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Brand NameALLEVYN GENTLE BORDER 10 X 10CM CTN 10
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key10491829
MDR Text Key205622279
Report Number8043484-2020-02733
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800270
Device Lot Number201848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
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 Initial

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