BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE PROCEDURE GLOVE

    MDR report key: 158264 · Received March 14, 1998

    Report

    Report Number
    MW1013352
    Event Type
    Other
    Date Received
    March 14, 1998
    Date of Event
    February 27, 1998
    Report Date
    March 5, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUT STERILE LATEX GLOVES ON TO PERFORM PROCEDURE. GLOVES ON APPROX 25 MINS. WHEN TAKEN OFF, NOTICED RED, HOT, ITCHY HANDS, SEVERE HIVES DOCUMENTED. BENADRYL 25 MGM PO TAKEN Q 6 HRS FOR 48 HRS. REDNESS & ITCHING LASTED 48 HRS AFTER THE EVENT. (INDIVIDUALS FIRST EXPOSURE TO LATEX GLOVES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE PROCEDURE GLOVE STERILE LATEX GLOVES LYY ALLEGIANCE HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other BENADRYL 25 MGM PO TAKEN