BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN MAXIMA PRO 45 N/O FIXED END

    MDR report key: 8796460 · Received July 16, 2019

    Report

    Report Number
    3007007357-2019-00004
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 8, 2019
    Manufacturer
    KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A SURGICAL EXTRACTION ON A FEMALE PATIENT, THE DENTIST NOTICED SWELLING AROUND THE PATIENT'S FACE AND WAS CONCERNED THAT THE EXHAUST AIR MAY HAVE CONTAMINATED THE EXTRACTION SITE. PATIENT WAS DIAGNOSED TO HAVE DEVELOPED SUBCUTANEOUS EMPHYSEMA AND WAS SUBMITTED TO AN URGENT CARE FACILITY OVERNIGHT. THE PATIENT WAS MONITORED AND RELEASED THE SUBSEQUENT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588896 HENRY SCHEIN MAXIMA PRO 45 N/O FIXED END HANDPIECE EFB KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA MAXIMA PRO 45 1705044

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization