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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE 15.4 X 15.4CM DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE 15.4 X 15.4CM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66021069
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2017
Event Type  malfunction  
Event Description
It was reported that the dressing placed on deltoid wounds. Dressing could not stay in place and could not manage moderate amount of drainage.
 
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Brand NameALLEVYN LIFE 15.4 X 15.4CM
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 Key6590094
MDR Text Key75929681
Report Number8043484-2017-00152
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
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number66021069
Device Catalogue Number66021069
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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