BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 6200726 · Received December 22, 2016

    Report

    Report Number
    1416605-2016-00010
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 17, 2016
    Report Date
    December 22, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    ELC
    PMA / PMN Number
    K012060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT CONTAINING INFORMATION AFTER THE DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE WAS INITIALLY REPORTED AS UI30SD100. THE DEVICE THAT WAS RETURNED AND SUBSEQUENTLY EVALUATED WAS UI25SD100.

    Additional Manufacturer Narrative · 1

    ON 12/21/2016, IT WAS REPORTED TO US BY (B)(6) THAT THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE USER FACILITY CONTACTED (B)(6), WHO FORWARDED THE COMPLAINT TO HU-FRIEDY. 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. NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE PATIENT WAS HAVING SCALING DONE WHEN THE TIP OF THE SCALER BROKE IN THE PATIENT'S MOUTH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE PATIENT WAS HAVING SCALING DONE WHEN THE TIP OF THE SCALER BROKE IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850129 HU-FRIEDY MFG. CO., LLC ULTRASONIC SCALER ELC HU-FRIEDY MFG. CO., LLC UI25SD100 1214

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other