BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRALON (LATEX POWDERED) BROWN

    MDR report key: 653174 · Received December 16, 2005

    Report

    Report Number
    1019632-2005-00011
    Event Type
    Injury
    Date Received
    December 16, 2005
    Report Date
    December 16, 2005
    Manufacturer
    ANSELL SHAH ALAM SDN. BHD
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT AN EMPLOYEE OPENED A PACK OF NEUTRALON SURGICAL GLOVES AND A SCALPEL CAME OUT INJURING THE EMPLOYEE. THE EMPLOYEE WAS TAKEN TO THE E.R. AND RECEIVED STITCHES. THE PACKAGES WERE LOOKED THROUGH AND A SECOND PACK WAS FOUND WITH ANOTHER SCALPEL INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUTRALON (LATEX POWDERED) BROWN SURGICAL GLOVES KGO ANSELL SHAH ALAM SDN. BHD 53-300 0501145321

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization