BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3865577 · Received June 2, 2014

    Report

    Report Number
    3865577
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 13, 2013
    Report Date
    June 2, 2014
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE MISFIRES OF THE APPLIER AND CLIPS WHICH FAILED TO CLOSE EITHER PARTIALLY OR COMPLETELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322120 * CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CORP CA090 1187176

    Patients

    Seq Age Sex Outcome Treatment
    1 *