BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4091406 · Received August 26, 2014

    Report

    Report Number
    4091406
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 26, 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

    UPON OPENING AN IMPLANT TRAY, IT WAS NOTED THAT THE 50CC BULB SYRINGE WAS MISSING. A 60CC SYRINGE WAS USED IN PLACE OF THE BULB SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515659 * TRAY, SURGICAL FSM MEDICAL ACTION INDUSTRIES, INC. * 966252

    Patients

    Seq Age Sex Outcome Treatment
    1 *