BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 198500 · Received November 24, 1998

    Report

    Report Number
    2084395-1998-00044
    Event Type
    Other
    Date Received
    November 24, 1998
    Report Date
    November 24, 1998
    Manufacturer
    SAFESKIN CORP
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON 10/26/1998, SAFESKIN CORP WAS SERVED WITH THE FOLLOWING LAWSUIT: PLAINTIFF'S CLAIM ALLEGES THE FOLLOWING: WHEEZING, TEARING OF THE EYES AND DIFFICULTY BREATHING. ON OR ABOUT 12/2/1996, PLAINTFF WAS DIAGNOSED AS BEING ALLERGIC TO LATEX. PLAINTIFF'S CONTINUED AND REPEATED EXPOSURE TO LATEX GLOVES CAUSED HIM TO SUFFER SEVERE AND IRREVERSIBLE TYPE-1 LATEX ALLERGY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other