BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO-TOUCH PF STERILE SURG 65

    MDR report key: 469364 · Received July 2, 2003

    Report

    Report Number
    1019632-2003-00004
    Event Type
    Other
    Date Received
    July 2, 2003
    Report Date
    July 2, 2003
    Manufacturer
    ANSELL SHAH ALAM SDN BHD
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THIS TYPE GLOVE WAS USED, HOWEVER, THEY COULD NOT BE 100% SURE OF THE LOT NUMBER USED. WHILE WEARING THE GLOVE...IT WAS NOTICED THAT FLUID HAD PENETRATED THE GLOVE. PT HAD TO BE RE-HOSPITALIZED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TOUCH PF STERILE SURG 65 MEDICAL GLOVE KGO ANSELL SHAH ALAM SDN BHD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization