BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP IMPLANT TRAY

    MDR report key: 4093764 · Received September 12, 2014

    Report

    Report Number
    4093764
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PACING CABLES WERE MISSING OUT OUT IMPLANT PACK. WE USED SINGLE STERILE PACING CABLES FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565918 EP IMPLANT TRAY TRAY, SURGICAL FSM MEDICAL ACTION INDUSTRIES, INC. * 966252

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR