BEUDAMED
    FDA Adverse Event Summary report: N

    LATEX DISPOSABLE GLOVE, NONSTERILE

    MDR report key: 19473 · Received November 21, 1994

    Report

    Report Number
    MW4000624
    Date Received
    November 21, 1994
    Report Date
    November 21, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    LYY
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR USED PRODUCT FOR 3 YEARS WITH NO REACTION. IN 12/92 OR 1/93, SHE HAD AN ALLERGIC REACTION WHICH SHE FEELS OCCURRED FROM GLOVES. DIAGNOSED 2/11/93. SKIN TEST REVEALED SERIOUS SENSITIVITY TO LATEX. ITCHING, HIVES AND HAND SWELLED 1ST REACTION. FOUR WEEKS LATER HAD 2ND REACTION WITH SNEEZING, THROAT SWELLING AND WATERY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX DISPOSABLE GLOVE, NONSTERILE LATEX GLOVE LYY PHARMASEAL DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *