BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXEVAC III

    MDR report key: 6011509 · Received October 7, 2016

    Report

    Report Number
    0001811755-2016-02541
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, WHEN THE PACKAGE WAS OPENED, A HAIR WAS DISCOVERED ON THE SPATULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662313 MIXEVAC III MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 16146012

    Patients

    Seq Age Sex Outcome Treatment
    1