BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY 1/2 GRACEY CURETTE

    MDR report key: 6733466 · Received July 21, 2017

    Report

    Report Number
    1416605-2017-00003
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 21, 2017
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EMS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. REPROCESSOR DOES NOT APPLY. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. USER FACILITY/IMPORTER DOES NOT APPLY. PMA/510(K) IS NOT APPLICABLE. IND IS NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY MFG. CO., LLC THAT DURING A DENTAL CLEANING PROCEDURE, THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. RETRIEVAL OF THE TIP WAS ATTEMPTED USING SUCTION. IT IS UNKNOWN WHETHER OR NOT THE TIP WAS SWALLOWED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513377 HU-FRIEDY 1/2 GRACEY CURETTE CURETTE, PERIODONTIC EMS HU-FRIEDY MFG. CO., LLC SG1/26 0414

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other