BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY 7/8 YOUNGER-GOOD CURETTE

    MDR report key: 7598883 · Received June 13, 2018

    Report

    Report Number
    1416605-2018-00004
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    April 11, 2018
    Report Date
    June 13, 2018
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EMS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HU-FRIEDY DOES NOT TRACK 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 CONCOMITANT MEDICAL PRODUCTS OR THERAPY DATES PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY MFG. CO., LLC THAT AN INSTRUMENT BROKE IN A PATIENT'S MOUTH DURING A PROCEDURE. THE TIP BECAME EMBEDDED IN THE GUM AND THE DENTIST OPENED A FLAP TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440237 HU-FRIEDY 7/8 YOUNGER-GOOD CURETTE CURETTE, PERIODONTIC EMS HU-FRIEDY MFG. CO., LLC SYG7/8 0311

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other