BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM SURGICAL GLOVES

    MDR report key: 2181357 · Received July 21, 2011

    Report

    Report Number
    MW5021491
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS EXPOSED TO CARDINAL HEALTH ESTEEM AND/OR PROTEGRITY SURGICAL GLOVES AND HAD AN ANAPHYLACTIC REACTION. PHYSICIAN WAS GIVEN BENADRYL AND EPINEPHRINE TO SAVE HIS LIFE. PHYSICIAN WAS ADMITTED FROM THE ER AND TRANSFERRED TO THE INTENSIVE CARE UNIT WITH A LENGTH OF STAY OF 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTEEM SURGICAL GLOVES SURGICAL GLOVES KGO CARDINAL HEALTH NA
    2 PROTEGRITY SURGICAL GLOVES SURGICAL GLOVES KGO CARDINAL HEALTH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L