BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 206091 · Received January 13, 1999

    Report

    Report Number
    2084395-1999-00002
    Event Type
    Other
    Date Received
    January 13, 1999
    Report Date
    January 13, 1999
    Manufacturer
    SAFESKIN CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON DECEMBER 15, 1998, SAFESKIN WAS SERVED WITH THE FOLLOWING LAWSUIT: PLAINTIFF'S CLAIM ALLEGES THE FOLLOWING: ON APRIL 10, 1995, PLAINTIFF CONTACTED DEFENDANTS TO ASK WHETHER SHE MIGHT BE ALLERGIC TO LATEX. ON APRIL 12, 1995, PLAINTIFF WAS TESTED AND ASKED TO BLOW UP A BALLON. PLAINTIFF DID BLOW UP A BALLON AND WHEN SHE ARRIVED IN THE OFFICE SHE EXHIBITED SIGNS OF WATERY EYES AND NASAL CONGESTION. FOLLOWING THE TEST, PLAINTIFF WAS GIVEN A BLOOD TEST WHEREBY SHE WAS TESTED POSITIVE FOR LATEX ALLERGIES. ON THE EVENING OF DECEMBER 12, 1995, PLAINTIFF ACCOMPANIED HER SISTER TO HOSPITAL EMERGENCY ROOM BECAUSE HER NIECE WAS SUFFERING FROM A HIGH FEVER. PLAINTIFF WAS EXPOSED TO LATEX GLOVES MANUFACTURED BY AT LEAST 3 DIFFERENT CORPORATIONS INCLUDING DEFENDANTS, BAXTER, SAFESKIN & STERIIFX. LATER THAT EVENING, PLAINTIFF SUFFERED A VIOLENT ANAPHYLACTIC REACTION WHICH REQUIRED HER TO SEEK IMMEDIATE ATTENTION. ALLEGED INJURIES: RESPIRATORY DIFFICULTIES, WHICH LED TO ANAPHYLAXIS WHICH PRODUCED ANAPHYLACTIC SHOCK AND CAUSED CARDIAC DAMAGE AND PUT PLAINTIFF INTO A COMA.

    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