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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 66021306
Device Problem Material Integrity Problem (2978)
Patient Problem Skin Tears (2516)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, the allevyn life sacrum is "shedding" silicone onto the patient upon removal and it's difficult to remove from the skin. It's also shedding as the backing is removed before application. It is unknown how the procedure was finished or if there was any delay.
 
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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 east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11057262
MDR Text Key223192436
Report Number8043484-2020-04350
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number66021306
Device Catalogue Number66801306
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 Received03/01/2021
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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