• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X20CM DRESSING,WOUND,OCCLUSIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X20CM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800900
Device Problem Material Disintegration (1177)
Patient Problem No Patient Involvement (2645)
Event Date 08/31/2020
Event Type  malfunction  
Event Description
It was reported that the silicone of the allevyn is offsetting, there were silicone residues left in the backing paper. No patient was involved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLEVYN GENTLE BORDER 10X20CM
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
holly topping
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
5123913905
MDR Report Key10702074
MDR Text Key212050927
Report Number8043484-2020-03243
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 11/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800900
Device Lot Number201901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
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

-
-