BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOJECT

    MDR report key: 2253730 · Received August 19, 2011

    Report

    Report Number
    8021764-2011-00005
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 20, 2010
    Report Date
    August 19, 2011
    Manufacturer
    OWEN MUMFORD LTD.
    Product Code
    KZH
    PMA / PMN Number
    K345660
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION HAS BEEN COMPLETED (ATTACHED) PREVENTATIVE/CAPA ACTIONS BEING PROGRESSED.

    Description of Event or Problem · 1

    (B)(6) CLINIC REPORTED TO OWEN MUMFORD INC. ISSUES WITH THE AUTOJECT EI DEVICE. (B)(6)REPORTED THAT THEIR CUSTOMER WAS UNABLE TO LOAD A SYRINGE IN THE DEVICE BECAUSE THE SPRING/COCKING MECHANISM WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOJECT AUTOJECT EI KZH OWEN MUMFORD LTD. NA KMG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other