BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #100 THIN UNIVERSAL STREAMLINE, 30KHZ

    MDR report key: 3851947 · Received April 11, 2014

    Report

    Report Number
    1416605-2014-00004
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    January 31, 2014
    Report Date
    April 8, 2014
    Manufacturer
    HU-FRIEDY MFG. CO.,INC.
    Product Code
    ELC
    PMA / PMN Number
    K953919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRACTICE RETURNED THE BROKEN DEVICE WITHOUT THE TIP TO HU-FRIEDY ON (B)(4) 2014 (THE TIP WAS NOT RETRIEVED). THE RETURNED DEVICE WAS REVIEWED AND IT WAS DETERMINED THAT THE FRACTURE ORIGINATED ON THE TOP SIDE OF THE DEVICE NEAR THE TIP. THE DEVICE SHOULD BE USED ON THE SIDES OF THE TIP (NOT ON THE TOP OR UNDERSIDE). THEREFORE, IT WAS CONCLUDED THAT USER ERROR WAS A CONTRIBUTING FACTOR IN THIS EVENT. WEIGHT AND AGE OF PATIENT IS NOT KNOWN. (B)(4) DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS I DEVICES, BY SERIAL NUMBER UDI #, ONLY A LOT # 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. THE PHONE NUMBER AND EMAIL ADDRESS OF THE INITIAL REPORTED WERE NOT KNOWN. THE (A) NDA#, IND#, AND BLA# ARE NOT APPLICABLE TO THIS CLASS II DEVICE.

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE ON (B)(6) 2014, THE TIP OF THE DEVICE BROKE IN THE PATIENT'S MOUTH. THE TIP WAS VISIBLE IN THE PATIENT'S MOUTH, SO THE AREA WAS SUCTIONED. AFTER THE AREA WAS SUCTIONED, THE TIP COULD NO LONGER BE SEEN. THE PATIENT DECLINED AN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221189 #100 THIN UNIVERSAL STREAMLINE, 30KHZ ULTRASONIC INSERT ELC HU-FRIEDY MFG. CO.,INC. UI30K100S 0113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES