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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN AG NON-ADHESIVE DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN AG NON-ADHESIVE DRESSING, WOUND, OCCLUSIVE Back to Search Results
Catalog Number UNKN05000505
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Skin Infection (4544)
Event Date 05/25/2021
Event Type  Injury  
Event Description
It was reported that, during treatment with allevyn ag non-adhesive to treat patients with skin graft for dehisced, a patient indicated that there were signs and symptoms of infection present while using the dressing. It is unknown if/how the event was resolved. This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
 
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Brand NameUNKN ALLEVYN AG NON-ADHESIVE
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 Key12005477
MDR Text Key256453298
Report Number8043484-2021-01480
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,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN05000505
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 Received09/06/2021
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

Patient Treatment Data
Date Received: 06/15/2021 Patient Sequence Number: 1
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