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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN AG GENTLE BORDER; DRESSING,WOUND,OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN AG GENTLE BORDER; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800438
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Event Description
The dressing is not absorbent enough, especially when compared to mepilex border ag of the same size.
 
Event Description
It was reported that the dressing is not absorbent enough compared to similar product from other brands.
 
Manufacturer Narrative
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.No complaint sample was provided for assessment.A review of our database has found this complaint to be the only complaint received for this issue for this product code and lot number therefore deemed an isolated incident.The investigation did not find product defect or manufacturing process issue so no action is required at present.Once a sample is received, we will assess and make 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.
 
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Brand Name
UNKNOWN ALLEVYN AG GENTLE BORDER
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK 
MDR Report Key8224478
MDR Text Key132344624
Report Number8043484-2019-00021
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,foreig
Type of Report Initial,Followup,Followup
Report Date 02/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800438
Device Lot Number201748
Date Manufacturer Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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