BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT - YELLOW POLISHING CUP

    MDR report key: 15715549 · Received November 1, 2022

    Report

    Report Number
    MW5113020
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    August 10, 2022
    Report Date
    October 31, 2022
    Manufacturer
    COLTENE / WHALEDENT INC.
    Product Code
    EJQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    POLISHING CONE (DRILL BIT) DISLODGED AND DROPPED INTO PATIENT'S MOUTH, PATIENT SWALLOWED. INSTITUTION RECENTLY MADE AWARE PT UNDERWENT COLONOSCOPY AND LATER PASSED DRILL BIT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949025 DRILL BIT - YELLOW POLISHING CUP WHEEL, POLISHING AGENT EJQ COLTENE / WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention