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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN AG GENTLE BORDER DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN AG GENTLE BORDER DRESSING, WOUND, OCCLUSIVE Back to Search Results
Catalog Number UNKN05000502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Skin Infection (4544)
Event Date 05/27/2021
Event Type  Injury  
Event Description
It was reported that, when using allevyn ag gentle border to treat patients with burns, it was reported that, in regards prevention of infection, even using the dressing it was necessary to prescribe antibiotics. 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 GENTLE BORDER
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 Key12025803
MDR Text Key257232941
Report Number8043484-2021-01529
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN05000502
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 Received09/09/2021
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: 06/18/2021 Patient Sequence Number: 1
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