• 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 12.5 X 12.5 CTN 10 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 12.5 X 12.5 CTN 10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800272
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2020
Event Type  malfunction  
Event Description
It was reported that during treatment the exudate was leaking from the dressing. The dressing does not stock. This incident did not caused an adverse event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLEVYN GENTLE BORDER 12.5 X 12.5 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 Key9969968
MDR Text Key190429029
Report Number8043484-2020-00292
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800272
Device Lot Number201944
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
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?
Type of Device Usage Initial

-
-