BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX GLOVE

    MDR report key: 34385 · Received July 23, 1996

    Report

    Report Number
    MW1009553
    Event Type
    Injury
    Date Received
    July 23, 1996
    Date of Event
    November 1, 1992
    Report Date
    July 22, 1996
    Manufacturer
    UNKNOWN
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR DEVELOPED SWOLLEN EYES, COUGHING, AND RASHES AROUND HER EYES. IT CONTINUED FROM 12/92 TO 8/95. SHE WAS EXPOSED TO LATEX AND DEVELOPED RASHES ON HER SKIN. ON 10/95, SHE DEVELOPED ASTHMA WHEN SHE WAS AROUND SOMEONE THAT WORE THE DEVICE. ON 11/13/95, SHE HAD A SIGNIFICANT ASTHMA ATTACK AND AN ANAPHYLACTIC REACTION. SHE WAS ACCIDENTALLY EXPOSED 2 OR 3 TIMES AFTER 11/95. ON 2/13/96 SHE WAS AGAIN ACCIDENTALLY EXPOSED AND HAD ANOTHER ATTACK AND SHE CONSIDERS THIS ATTACK AS UFE-THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX GLOVE LATEX GLOVE LYY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| S