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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66801306
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Ulcer (2274)
Event Date 05/26/2017
Event Type  Injury  
Event Description
It was reported dressing was placed on fully intact skin as a prophylactic measure, upon removal of dressing pt's skin is macerated and she now has a stage 2 pressure ulcer.
 
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Brand NameALLEVYN LIFE SACRUM (SMALL) PACK OF 10
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 
SZ  
MDR Report Key6686252
MDR Text Key79057402
Report Number8043484-2017-00169
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number66801306
Device Catalogue Number66801306
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 Received06/02/2017
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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