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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN DURAMAX

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SMITH & NEPHEW MEDICAL LTD. UNKN DURAMAX Back to Search Results
Catalog Number UNKN05005801
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Impaired Healing (2378); Tissue Breakdown (2681)
Event Date 06/01/2021
Event Type  Injury  
Event Description
It was reported that, when using duramax dressing to treat patients with partial thickness burns/superficial burns, removing the dressing was very painful for the patient. The dressing was completely macerated before removal. Then it was easier to remove the dressing. 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, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
 
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Brand NameUNKN DURAMAX
Type of DeviceUNKN DURAMAX
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 Key12068369
MDR Text Key258612444
Report Number8043484-2021-01582
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeGM
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN05005801
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 Received08/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/25/2021 Patient Sequence Number: 1
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