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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE 12.9 X 12.9CM DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE 12.9 X 12.9CM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66021068
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Skin Irritation (2076)
Event Date 04/27/2017
Event Type  Injury  
Event Description
It was reported that the allevyn is not wicking away drainage, sitting on top of dressing, causing maceration to peri wound.
 
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Brand NameALLEVYN LIFE 12.9 X 12.9CM
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(SUZHOU) LIMITED.
no.12 wuxiang road.
suzhou, jiangsu province 21502 1
CH 215021
Manufacturer Contact
markus poettker
schachenallee 29
SZ   5001
MDR Report Key6614640
MDR Text Key76752846
Report Number8043484-2017-00156
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number66021068
Device Catalogue Number66021068
Device Lot Number201632
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 Received05/08/2017
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

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