BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMA PRO 45 N/O FIXED END

    MDR report key: 15522564 · Received October 1, 2022

    Report

    Report Number
    3007007357-2022-00013
    Event Type
    Injury
    Date Received
    October 1, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 29, 2022
    Manufacturer
    HANDPIECE HEADQUARTERS
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HISTORY ON THE HANDPIECE WAS RETRIEVED WHICH STATED THAT IT WAS PURCHASED ON 05/31/19 AND WAS SENT IN FOR REPAIR TWICE (04/13/21 FOR WARRANTY REPAIR & 11/09/21 WHERE A NEW TURBINE WAS INSTALLED BY HANDPIECE HEADQUARTERS).

    Description of Event or Problem · 0

    PATIENT APPEARED TO HAVE SWALLOWED SURGICAL BUR (560L) DURING TORI REMOVAL AND ALVEOPLASTY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171538 MAXIMA PRO 45 N/O FIXED END HANDPIECE EFB HANDPIECE HEADQUARTERS MAXIMA PRO 45

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other