BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER

    MDR report key: 491880 · Received October 17, 2003

    Report

    Report Number
    491880
    Event Type
    Other
    Date Received
    October 17, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 1, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EFA
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF A TOOTH DURING A DENTAL EXTRACTION IT WAS NOTED THAT THERE WAS A DEFECT IN THE STRYKER HANDPIECE. A SMALL PORTION OF THE HANDPIECE HAS HEATED UP AND BURNED THE PT'S LOWER LIP IN 2 DISTINCT SPOTS. THE OPERATING ROOM STAFF NOTED 2 REDDENED AREAS. ONE AREA WAS ON THE LIP AND ONE WAS BELOW THE LIP ON THE CHIN. NO BLISTERING WAS REPORTED. THE SIZE OF THE BURNS IS UNK. THE BURNS WERE TREATED WITH SILVADENE AND DIPROLENE .5% OINTMENT AND THE LIP IS REPORTEDLY HEALING. THE PT LATER REPORTED HAVING GONE TO A SECOND PHYSICIAN, A PLASTIC SURGEON, WHO GAVE A SECOND OPINION STATING THE BURN AS "THIRD DEGREE". THE BURN IS BELIEVED TO BE A THERMAL BURN CAUSED BY HEAT GENERATION OF THE MOTOR IN THE HANDPIECE. NO SHORTS IN THE CORD WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER HANDPIECE EFA STRYKER INSTRUMENTS 5100-100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other