BEUDAMED
    FDA Adverse Event Other Summary report: N

    LATEX EXAM GLOVES

    MDR report key: 473642 · Received July 25, 2003

    Report

    Report Number
    1423507-2003-00092
    Event Type
    Other
    Date Received
    July 25, 2003
    Date of Event
    February 28, 1995
    Report Date
    July 25, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT BEGAN WORKING AS A DENTAL ASSISTANT IN APPROXIMATELY 1990. PT FURTHER ALLEGES THAT THEY CONTINUED TO WORK AS A CERTIFIED AND REGISTERED DENTAL ASSISTANT UNTIL 1995, WHEN THEY LEFT THEIR OCCUPATION DUE TO DEVELOPING TYPE I IMMEDIATE HYPERSENSITIVITY TO LATEX. THEY ALSO ALLEGE THAT THEY DEVELOPED TYPE I, LIFE THREATENING IMMEDIATE HYPERSENSITIVITY TO LATEX AS A RESULT OF THEIR EXPOSURE TO NRL ALLERGENS FROM THE LATEX GLOVES THEY WORE AND THE LATEX GLOVES WHICH DENTAL PERSONNEL WORE AROUND THEM DUE TO BOTH CUTANEOUS CONTACT AND AIRBORNE EXPOSURE TO AEROALLERGENS. FURTHERMORE THEY ALLEGE THAT THEY HAVE IN THE PAST AND WILL CONTINUE IN THE FUTURE TO BE REQUIRED TO EXPEND MONIES FOR MEDICAL CARE AND TREATMENT AS A RESULT OF THEIR INJURIES AND WILL SUFFER WAGE LOSS AND LOSS OF EARNING CAPACITY. THEY ALLEGE THAT THEY HAVE BEEN CAUSED TO SUFFER GREAT PAIN AND SUFFERING AND WILL CONTINUE TO SUFFER IN THE FUTURE. THEY ALSO ALLEGE THAT THEIR SEVERE SENSITIZATION TO LATEX HAS CAUSED SEVERE RESTRICTIONS IN THEIR LIFE AS TO WHERE THEY CAN GO AND WHAT THEY CAN DO TO AVOID LIFE TREATENING REACTIONS. FURTHERMORE, THEY ALLEGE THAT IS HAS ALSO CAUSED TREMENDOUS MENTAL STRAIN AND EMOTIONAL STRESS BECAUSE OF THE DRASTIC CHANGES IN THEIR LIFE AS WELL AS THE LIVES OF THEIR FAMILY. THEY ALLEGE THAT THE DEFENDANTS FAILED TO WARN THEM OF THE RISK OF SENSITIZATION TO LATEX AND ALLERGIC REACTIONS, ESPECIALLY LIFE THREATENING REACTIONS; AND THAT THE DEFENDANTS FAILED TO ENSURE THAT THE GLOVES WERE SAFE FOR HEALTHCARE WORKERS WHO WOULD BE WEARING THEM ALL DAY. THEY ALSO ALLEGE THAT THEY HAVE SUFFERED HUMILATION, ANXIETY, EMBARRASSMENT, OUTRAGE, AND OTHER MENTAL SUFFERING AND SEVERE EMOTIONAL DISTRESS. FINALLY, THE PT'S SPOUSE ALLEGES THAT THEY SUFFERED THE LOSS OF SUPPORT, SERVICES AND COMPANIONSHIP OF THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other