BEUDAMED
    FDA Adverse Event Other Summary report: N

    LATEX EXAM GLOVES

    MDR report key: 147165 · Received February 4, 1998

    Report

    Report Number
    1423507-1998-00026
    Event Type
    Other
    Date Received
    February 4, 1998
    Date of Event
    January 25, 1996
    Report Date
    February 4, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES SEVERE AND IMMEDIATE REACTIONS TO LATEX GLOVES AND HAS SUSTAINED SERIOUS SEVERE AND PERMANENT BODILY INJURIES, PAIN AND SUFFERING AND WILL IN THE FUTURE. FURTHER ALLEGES SUSTAINING NUMEROUS INJURIES INCLUDING ASTHMA, RHINITIS, RESPIRATORY PROBLEMS, HIVES, CONTACT DERMATITIS, THROAT SORENESS, FATIGUE, HEADACHES, EXTREME DISCOMFORT, DEPRESSION AND EMOTIONAL DISTRESS. PLAINTIFF ALLEGES THAT SHE HAS BEEN FORCED TO EXPEND SUMS OF MONEY FOR MEDICAL CARE AND TREATMENT AND WILL CONTINUE TO BE CAUSED TO DO SO INDEFINITELY. ANOTHER PLAINTIFF AND WITH OF PLAINTIFF ALLEGES LOSS OF CONSORTIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX EXAM GLOVES LATEX EXAM GLOVES LYY ALLEGIANCE HEALTHCARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other