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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 5.5X12CM; DRESSING,WOUND,OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 5.5X12CM; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800836
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2019
Event Type  malfunction  
Event Description
Did not wick moisture from skin.
 
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.The database of change controls for the agb lite product family was reviewed and it was found there were no changes to raw materials, manufacturing methods or equipment since the original qualification exercises that could have contributed to the issue experienced by the customer or alleged adverse reaction.The investigation did not find product defect or manufacturing process issue.The complaint sample was not available at this time.Once the sample received, an assessment may take place to make further investigation.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.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.
 
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Brand Name
ALLEVYN GENTLE BORDER LITE 5.5X12CM
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK 
MDR Report Key8377969
MDR Text Key137405768
Report Number8043484-2019-00142
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 health professional,user faci
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800836
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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