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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE 8IN X 8IN DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE 8IN X 8IN DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800258
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); Injury (2348)
Event Date 02/08/2018
Event Type  Injury  
Event Description
It was reported that a few different patients have suffered from denuded skin and/or dermatitis under allevyn gentle dressings used under compression.
 
Manufacturer Narrative
Our investigation into this complaint has now concluded. As of today, no additional information requested or sample 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. An investigation into the manufacturing paperwork associated with this product code and lot has been carried out. This review detailed that manufacture of the product had occurred in accordance with defined procedures and specifications. Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments. ¿insufficient clinically relevant supporting documentation was provided to perform a thorough medical investigation. Therefore, no further medical assessment is warranted at this time. 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 NameALLEVYN GENTLE 8IN X 8IN
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
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key7319644
MDR Text Key101688864
Report Number8043484-2018-00041
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66800258
Device Lot Number1650
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 Received02/08/2018
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

Patient Treatment Data
Date Received: 03/07/2018 Patient Sequence Number: 1
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