BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXEVAC III

    MDR report key: 3777741 · Received April 29, 2014

    Report

    Report Number
    0001811755-2014-01542
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION WAS NOT CONFIRMED UPON EVALUATION OF THE RETURNED PRODUCT. NEITHER THE INNER/OUTER POUCH NOR THE TYVEK PAPER PRESENTED ANY PHYSICAL DAMAGE (I.E. CUT, TEARING, OR PUNCTURE). THE INNER POUCH DID PRESENT SOME SCRATCHES FROM THE INSIDE CAUSED BY THE RUBBING OF THE MIXEVAC BOWL OR HANDLE AGAINST THE PLASTIC BAG. HOWEVER, THERE WAS NO PERFORATION ON THE AREA. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE MIXEVAC III FOR A PROCEDURE, A SLICE WAS FOUND IN THE PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE MIXEVAC III FOR A PROCEDURE, A SLICE WAS FOUND IN THE PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256741 MIXEVAC III MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13327012

    Patients

    Seq Age Sex Outcome Treatment
    1