BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 200831 · Received December 8, 1998

    Report

    Report Number
    2084395-1998-00046
    Event Type
    Other
    Date Received
    December 8, 1998
    Report Date
    December 8, 1998
    Manufacturer
    SAFESKIN CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 9, 1999, SAFESKIN CORPORATION WAS SERVED WITH A LAWSUIT. PLAINTIFF'S CLAIM ALLEGES THAT PLAINTIFF WAS EXPOSED TO LATEX CONTAINING PRODUCTS, AND THE LATEX DUST AND VARIOUS POWDER ADDITIVES EMITTED FROM THE VARIOUS LATEX CONTAINING PRODUCTS CAUSED PLAINTIFF TO SUFFER THE FOLLOWING INJURIES: RHINITIS, RESPIRATORY PROBLEMS, HIVES, CONTACT DERMATITIS, SWELLING, FATIGUE, HEADACHES, EXTREME DISCOMFORT, DEPRESSION AND EMOTIONAL DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LATEX GLOVE LYY SAFESKIN CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other