BEUDAMED
    FDA Adverse Event Other Summary report: N

    LATEX EXAM GLOVES

    MDR report key: 313640 · Received January 26, 2001

    Report

    Report Number
    1423507-2001-00023
    Event Type
    Other
    Date Received
    January 26, 2001
    Date of Event
    June 30, 1994
    Report Date
    January 26, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    LYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PLAINTIFF ALLEGES THAT WHILE WORKING AS A REGISTERED NURSE WAS EXPOSED TO ANTIGENIC NATURAL LATEX PROTEINS IN THE LATEX GLOVES THAT THE PLAINTIFF WORE. THE PLAINTIFF ALLEGES THAT IN 1994, THE PLAINTIFF SUFFERED AN ANAPHYLACTIC REACTION TO LATEX GLOVES, WHICH FORCED THE PLAINTIFF TO LEAVE JOB AS A REGISTERED NURSE. THE PLAINTIFF FURTHER ALLEGES THAT HAS BECOME SENSITIZED TO LATEX AND CAN NO LONGER WORK AS A REGISTERED NURSE AT ANY MEDICAL FACILITY AND IS NOW SUBJECTED TO INCREASED HEALTH RISKS. FURTHERMORE THE PLAINTIFF ALLEGES THAT THE PLAINTIFF IS SUBJECT IN THE FUTURE TO ONE OR MORE ANAPHYLACTIC REACTIONS TO LATEX PRODUCTS. THE PLAINTIFF ALSO ALLEGES THAT THE PLAINTIFF HAS SUFFERED SUBSTANTIAL INJURY, PAIN AND SUFFERING AND ECONOMIC LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3304 LATEX EXAM GLOVES LATEX EXAM GLOVES LYX ALLEGIANCE HEALTHCARE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other