BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4373675 · Received December 16, 2014

    Report

    Report Number
    4373675
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 16, 2014
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON ATTEMPTED TO USE THE CLIP APPLIER ON THE BLEEDING VESSEL, IT JAMMED WITH MULTIPLE CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825289 * CLIP APPLER FZP APPLIED MEDICAL RESOURCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR