BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 6191870 · Received December 20, 2016

    Report

    Report Number
    1416605-2016-00009
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 19, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    ELC
    PMA / PMN Number
    K012060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS PRODUCED BEFORE THE UDI COMPLIANCE DUE DATE FOR THE PRODUCT AND THEREFORE UDI WAS NOT APPLIED. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NEITHER IMPLANTED OR EXPLANTED. REPROCESSOR DOES NOT APPLY. NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. IND IS NOT APPLICABLE.

    Description of Event or Problem · 1

    DURING A STANDARD CLEANING, THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE DENTIST ADVISED THE PATIENT TO GO TO THE EMERGENCY ROOM FOR AN X-RAY OR RADIOGRAPH. IT WAS REPORTED THAT THE EMERGENCY ROOM PHYSICIAN INFLATED HIS LUNG SO A SCOPE COULD BE DONE. IT WAS REPORTED THAT NOTHING WAS FOUND. IN A FOLLOW-UP, THE DENTIST REPORTED THAT THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841614 HU-FRIEDY MFG. CO., LLC ULTRASONIC INSERT ELC HU-FRIEDY MFG. CO., LLC UI30SD1000 1115

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other