BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAMAZINE CREAM 1% UK ONLY 500G JAR

    MDR report key: 10464015 · Received August 28, 2020

    Report

    Report Number
    8043484-2020-02676
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    January 1, 1901
    Report Date
    September 22, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NUP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: IN REVIEWING THE SUBJECT PRODUCT DETAILS, IT WAS DETERMINED THAT THIS EVENT WAS REPORTED TO FDA-CDRH IN ERROR. THE REFERENCED PART NUMBER IS A PHARMACEUTICAL PRODUCT AND NOT A MEDICAL DEVICE. ADDITIONALLY, THE PRODUCT IS NOT LICENSED/APPROVED FOR SALE IN THE US. THE CASE HAS BEEN LOGGED IN OUR COMPLAINT SYSTEM AND PHARMACOVIGILANCE DATABASE. THE EVENT OCCURRED IN THE UK AND WAS RECEIVED VIA EVWEB WHICH IS A SECURE ELECTRONIC GATEWAY TO THE EUROPEAN MEDICINES AGENCY AND ALL EEA COMPETENT AUTHORITIES FOR REPORTING PURPOSES. THEREFORE, THERE ARE NO ADDITIONAL REPORTING OBLIGATIONS FOR FDA.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928584 FLAMAZINE CREAM 1% UK ONLY 500G JAR CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER NUP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other