Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 SACRUM (SMALL) PACK OF 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 LIFE SACRUM (SMALL) PACK OF 10; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801306
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Event Description
It was reported that the wound care nurses were advising the patient that when they were assessing the allevyn life sacral dressing, the silicone was leaving large amounts of residue.
 
Manufacturer Narrative
We have now concluded our investigation for the complaint received.No dhr/batch record review was possible as no lot numbers have been made available.No complaint sample was available for assessment but a photograph was sent for evaluation and there was evidence of adhesive left on the skin and small silicone beads were visible on the surface.A review of our database has found this complaint to be the only complaint received for this issue for this product code therefore deemed an isolated incident.This issue will be raised with the raw material supplier for further investigation.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 Name
ALLEVYN LIFE SACRUM (SMALL) PACK OF 10
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key8151088
MDR Text Key130049033
Report Number8043484-2018-00433
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801306
Device Lot NumberUNKNOWN
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-