BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 4966058 · Received August 4, 2015

    Report

    Report Number
    2411236-2015-00006
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 23, 2015
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR HAD AN ALLERGIC REACTION TO THE GLOVES WHICH RESULTED IN NEEDING TO GO TO THE EMERGENCY ROOM. THE DOCTOR'S LEFT HAND WAS SWOLLEN AND HAD TO TAKE ANTIBIOTICS FOR ABOUT A WEEK. WE HAVE BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING TREATMENT AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507536 HENRY SCHEIN CRITERION CL GLOVE PF LATEX LYY WRP ASIA PACIFIC SDN. BHD. W406600502

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention