BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMA PRO 45 N/O FIXED END

    MDR report key: 15374400 · Received September 7, 2022

    Report

    Report Number
    3007007357-2022-00011
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 29, 2022
    Manufacturer
    HANDPIECE HEADQUARTERS
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER PATIENT HAS SWALLOWED THE SURGICAL BUR (541), PATIENT WENT TO PROMEDICA MONROE REGIONAL HOSPITAL FOR MEDICAL TREATMENT WHERE AN X-RAY WAS TAKEN AT EMERGENCY CENTER. NO FINDINGS, AND PATIENT HAS SINCE RETURNED TO DENTAL OFFICE WITH NO COMPLAINTS.

    Description of Event or Problem · 0

    PATIENT SWALLOWED SURGICAL BUR (541) DURING FULL MOUTH EXTRACTION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280273 MAXIMA PRO 45 N/O FIXED END HANDPIECE EFB HANDPIECE HEADQUARTERS MAXIMA PRO 45

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other