BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 208291 · Received February 2, 1999

    Report

    Report Number
    2084395-1999-00003
    Event Type
    Other
    Date Received
    February 2, 1999
    Report Date
    February 2, 1999
    Manufacturer
    SAFESKIN CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 11, 1999 SAFESKIN CORP WAS SERVED WITH THE FOLLOWING LAWSUIT: PLAINTIFF'S CLAIM ALLEGES THE FOLLOWING: DIAGNOSED AS SUFFERING FROM TYPE 1 LATEX ALLERGY. SOMETIME AFTER 01/01/1997 PLAINTIFF FIRST DISCOVERED THAT HER HEALTH WAS AT RISK AS A RESULT OF WORKING IN AN ENVIRONMENT IN WHICH ALLERGENIC LATEX GLOVES WERE IN USE.

    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