BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX

    MDR report key: 5093608 · Received September 22, 2015

    Report

    Report Number
    5093608
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EPIX UNIVERSAL CLIP APPLIER WOULD NOT FIRE.(TWO DEVICES FAILED TO OPERATE AS INTENDED PRIOR TO THE BEGINNING OF THIS CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626133 EPIX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CORP. CA500 1246690

    Patients

    Seq Age Sex Outcome Treatment
    1