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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FLAMAZINE CREAM 1% UK ONLY 500G JAR CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER

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SMITH & NEPHEW MEDICAL LTD. FLAMAZINE CREAM 1% UK ONLY 500G JAR CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER Back to Search Results
Catalog Number 66150155
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Injury (2348)
Event Date 01/01/1901
Event Type  Injury  
Event Description

It was reported that a case of toxic epidermal necrolysis was reported in a (b)(6) male patient which occurred in 2006 after use of multiple suspect drugs for toxic epidermal necrolysis and other unknown indication, which were used for an unknown period. The patient¿s relevant medical history includes: drug hypersensitivity, chest infection, pneumonia for which the patient was hospitalized also nephropathy which is ongoing, diabetes mellitus (non-insulin dependent) which is poorly managed and ongoing and alcoholic which is also ongoing. This case has been classed as serious and medically significant and the outcome is unknown. Due to the lack of information provided it has not been possible at this time to confirm whether the suspect drug sulfadiazine silver is a smith & nephew product.

 
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Brand NameFLAMAZINE CREAM 1% UK ONLY 500G JAR
Type of DeviceCREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER
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
sarah freestone
101 hessle road
hull east riding of yorkshire HU3 2-BN
UK   HU3 2BN
0447940038
MDR Report Key10464015
MDR Text Key204687096
Report Number8043484-2020-02676
Device Sequence Number1
Product Code NUP
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 09/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue Number66150155
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/28/2020 Patient Sequence Number: 1
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