BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CMS W/BREAKAWAY

    MDR report key: 2971390 · Received February 21, 2013

    Report

    Report Number
    0001811755-2013-00336
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF THE REVOLUTION CMS W/BREAKAWAY APPEARED TO BE CONTAMINATED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77034 REVOLUTION CMS W/BREAKAWAY MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 12356012

    Patients

    Seq Age Sex Outcome Treatment
    1