BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA INTERNATIONAL 1:5 HANDPIECE

    MDR report key: 10833955 · Received November 12, 2020

    Report

    Report Number
    3007007357-2020-00002
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 12, 2020
    Manufacturer
    B.A. INTERNATIONAL LTD.
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT NOTIFICATION AND HANDPIECE WAS INITIALLY SENT TO DENTSPLY SIRONA, BASED IN (B)(6); DENTSPLY SIRONA IS THE OEM FOR THIS HANDPIECE. UPON COMPLETING DEVICE EVALUATION, SIRONA INFORMED US THAT THIS HANDPIECE WAS DISTRIBUTED BY BA INTERNATIONAL LTD., AND INDICATED BA INTERNATIONAL'S BRAND NAME OF THE PRODUCT: CE LABEL 0476. DENTSPLY SIRONA HAS PROVIDED THEIR INVESTIGATION REPORT, ATTACHED TO THIS SUBMISSION. ADDITIONALLY, THE HANDPIECE WILL BE RETURNED BACK TO HANDPIECE HEADQUARTERS AND BE READILY AVAILABLE FOR BA INTERNATIONAL'S EVALUATION. THIS REPORT HAS ALSO BEEN SENT TO BA INTERNATIONAL.

    Description of Event or Problem · 1

    A CHILD PATIENT FELT BURNING SENSATION. THIS HANDPIECE WAS ALSO USED ON A SECOND FEMALE PATIENT AND A BURNING SENSATION WAS ALSO OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292474 BA INTERNATIONAL 1:5 HANDPIECE HANDPIECE EGS B.A. INTERNATIONAL LTD. BA250LT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other