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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE NON-BRDR 21X21CM CTN10; DRESSING,WOUND,OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE NON-BRDR 21X21CM CTN10; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801750
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2019
Event Type  malfunction  
Event Description
It was reported that product does not absorb drainage.
 
Manufacturer Narrative
We have now concluded our investigation into this complaint.As of today, no additional information or sample requested for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.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.A review of the associated batch manufacturing records was not possible due to lot number being supplied.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 LIFE NON-BRDR 21X21CM CTN10
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK 
MDR Report Key8372683
MDR Text Key137255239
Report Number8043484-2019-00139
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 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801750
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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