• 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 S 10.3X10.3 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 S 10.3X10.3 CTN10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801067
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2018
Event Type  malfunction  
Event Description
It was reported that the patients had problems with the absorption of the product allevyn life. There were cases where the exchange have been carried out with 1 day of dressing's use with lesions of medium exudation. The dressing is saturating and leaking exudate at the edges and not at the center of the foam.
 
Manufacturer Narrative
We have now concluded our investigation into this complaint. Unfortunately no sample has been provided preventing a more thorough investigation, the photos have been assessed however unfortunately do not help identify the root cause of the reported issue. The free swell absorption of batch 201512 was tested at the time of release and the result was 131g/cm2 within the specification of no less than 94g/cm2. A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant. In addition it can be confirmed that all finished product specification testing was satisfied at the point of release. In the absence of additional information, our investigation remains inconclusive. At this time an exact root cause cannot be determined. If additional information becomes available in the future, this case will be reopened. Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products. We will continue to monitor for any adverse trends relating to this product range.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLEVYN LIFE S 10.3X10.3 CTN10
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 8N
UK HU3 28N
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 8N
UK HU3 28N
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7451067
MDR Text Key106254112
Report Number8043484-2018-00094
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66801067
Device Lot Number201512
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-