• 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 LIFE L 15.4X15.4 CTN10 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 LIFE L 15.4X15.4 CTN10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66801069
Device Problems Loss of or Failure to Bond (1068); Defective Device (2588)
Patient Problem Skin Infection (4544)
Event Date 02/12/2021
Event Type  Injury  
Event Description
It was reported that, during treatment, customer stated that allevyn device form of absorption does not occur in a vertical way, but in a transversal way, macerating the margins. There is also the displacement of the covering on the skin causing the edges to curl, implying frequent changes of the covering. Also, complained that the packaging / seal for being transparent is difficult to release the foam, compromising the application of the product and the aseptic technique. The treatment was completed without delay using a smith & nephew back-up device. No other complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLEVYN LIFE L 15.4X15.4 CTN10
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
holly topping
101 hessle road
hull east riding of yorkshire HU3 2-BN
UK   HU3 2BN
5123913905
MDR Report Key11478989
MDR Text Key239683983
Report Number8043484-2021-00563
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number66801069
Device Catalogue Number66801069
Device Lot Number202022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/14/2021 Patient Sequence Number: 1
-
-