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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE S 10.3X10.3 CTN10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE S 10.3X10.3 CTN10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66801067
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation (2443)
Event Date 03/15/2017
Event Type  Injury  
Event Description
It has recently reported cases of dermatitis, folliculitis, and maceration associated with the allevyn life dressing.
 
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Brand NameALLEVYN LIFE S 10.3X10.3 CTN10
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer Contact
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6499434
MDR Text Key72984950
Report Number8043484-2017-00116
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number66801067
Device Catalogue Number66801067
Device Lot Number201631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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