BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 17320506 · Received July 13, 2023

    Report

    Report Number
    2411236-2023-00002
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 16, 2023
    Report Date
    June 19, 2023
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AK, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    A 28 YEAR OLD FEMALE ASSISTANT HAD PUT LATEX GLOVES ON AND EXPERIENCED A RASH WHERE THE GLOVES TOUCHED HER HANDS AS WELL AS A FEELING OF TIGHTNESS IN HER CHEST. AS A RESULT SHE HAD TO BE ADMINISTERED EPINEPHRINE WHILE AT THE OFFICE TO HELP TREAT. AS OF TODAY THE FEMALE ASSISTANT IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862115 HENRY SCHEIN CRITERION LATEX SURGICAL GLOVE KGO WRP ASIA PACIFIC SDN. BHD. W102690365

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention