BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 1150011 · Received August 27, 2008

    Report

    Report Number
    1811755-2008-00047
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND PIECE LEAKED OIL AFTER STERILZATION, THERE WAS NO CONTACT WITH THE PATIENT OR THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO DRILL WITH HANDSWITCH PNEUMATIC DRILL HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK