BEUDAMED
    FDA Adverse Event Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 5992317 · Received September 30, 2016

    Report

    Report Number
    1416605-2016-00007
    Date Received
    September 30, 2016
    Date of Event
    August 30, 2016
    Report Date
    October 17, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EMS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT: ON (B)(6) 2016, THE PATIENT'S MOTHER CALLED THE (B)(6) TO REPORT THAT THE PATIENT HAD PASSED THE TIP. UPDATED FIELDS: THE PATIENTS AGE HAS BEEN UPDATED. THE DATE OF EVENT HAS BEEN UPDATED. PATIENT'S RELEVANT HISTORY HAS BEEN UPDATED. THE OPERATOR OF THE DEVICE HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641258 HU-FRIEDY MFG. CO., LLC CURETTE EMS HU-FRIEDY MFG. CO., LLC SBH5/6C8 0712

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other