BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 5985860 · Received September 28, 2016

    Report

    Report Number
    1416605-2016-00006
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 28, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    ELC
    PMA / PMN Number
    K012060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH, RESULTING IN THE OPENING OF A FLAP TO REMOVE THE FRAGMENTED PIECE. THE REASON AS TO THE BREAKAGE OF THE INSERT IS IN PROCESS OF BEING EVALUATED. PATIENT IDENTIFIER IS UNKNOWN. AGE OF PATIENT IS UNKNOWN. SEX OF PATIENT IS UNKNOWN. WEIGHT OF PATIENT IS UNKNOWN. THERE ARE NO RELEVANT TESTS/LABORATORY DATA. THERE IS NO RELEVANT HISTORY. HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    THE DENTIST WAS USING THE INSTRUMENT ON A PATIENT WHEN THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE DOCTOR HAD TO OPEN A TISSUE FLAP IN ORDER TO RETRIEVE THE BROKEN PIECE. ALL BROKEN PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635673 HU-FRIEDY MFG. CO., LLC ULTRASONIC INSERT ELC HU-FRIEDY MFG. CO., LLC UI30SD100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other