BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE LATEX GLOVE

    MDR report key: 35654 · Received August 16, 1996

    Report

    Report Number
    MW1009738
    Event Type
    Other
    Date Received
    August 16, 1996
    Date of Event
    June 27, 1996
    Report Date
    August 2, 1996
    Manufacturer
    SURGICAL GROUP BAXTER HEALTHCARE CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REACTION TO LATEX GLOVES ON MORE THAN ONE OCCASION. EVENT ON 6/27/96 REQUIRED TREATMENT IN ER. RASH WITH SEVERE ITCHING FOLLOWING THE WEARING OF LATEX GLOVES. RASH ON HANDS, ARMS, ABDOMEN, FACIAL FLUSHING, EDEMA OF HANDS, DIFFICULTY BREATHING. SENT TO DERMATOLOGIST/ALLERGIST, "GLOVE TEST" POSITIVE, SCRATCH TEST NEGATIVE, INTRADERMAL TEST QUITE POSITIVE AT A 4+ LEVEL (MAXIMUM REACTION THAT COULD BE MEASURED). ADD'L EVENT DATE 7/9/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE LATEX GLOVE LATEX GLOVE LYY SURGICAL GROUP BAXTER HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other