BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER

    MDR report key: 2201020 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02362
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAST CUTTER OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAST CUTTER HAB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK