BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORE MICRO DRILL

    MDR report key: 2042107 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01031
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE STRYKER MICRO DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PT SUSTAINED A BURN TO THE SKIN. THE BURN WAS TREATED WITH AN UNK OINTMENT. THE PT HAS NOT BEEN SEEN OR EVALUATED BY THE PHYSICIAN SINCE THE INCIDENT, AS THE PT DID NOT RETURN TO THE PHYSICIAN'S OFFICE FOR A F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE MICRO DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention