BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 19465712 · Received June 5, 2024

    Report

    Report Number
    3010364969-2024-00012
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    February 27, 2024
    Report Date
    August 26, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE 62-YEAR-OLD MALE PATIENT WAS RECEIVING FULL MOUTH EXTRACTIONS AND THE BUR, ITEM # 1008502 SURGICAL BUR FG 557 CAME OUT OF THE HANDPIECE AND WENT DOWN THEIR THROAT. THE PATIENT TRIED TO COUGH AND MAKE THEMSELVES THROW UP BUT WAS UNSUCCESSFUL. THE PATIENT WAS GIVEN A REFERRAL TO THE URGENT CARE AND THEY WERE REPORTED TO COME BACK TO THE PRACTICE ON (B)(6) 2024 FOR POST OP. IT WAS THEN CONFIRMED THAT THE PATIENT SWALLOWED THE BUR AND WENT TO THE URGENT CARE FOR THE XRAY.

    Description of Event or Problem · 0

    THE 62 YEAR OLD MALE PATIENT WAS RECEIVING FULL MOUTH EXTRACTIONS AND THE BUR, ITEM # 1008502 SURGICAL BUR FG 557 CAME OUT OF THE HANDPIECE AND WENT DOWN THEIR THROAT. THE PATIENT TRIED TO COUGH AND MAKE THEMSELVES THROW UP BUT WAS UNSUCCESSFUL. THE PATIENT WAS GIVEN A REFERRAL TO THE URGENT CARE AND THEY WERE REPORTED TO COME BACK TO THE PRACTICE ON (B)(6) 2024 FOR POST OP. IT WAS THEN CONFIRMED THAT THE PATIENT SWALLOWED THE BUR AND WENT TO THE URGENT CARE FOR THE XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854799 HENRY SCHEIN HANDPIECE EFB TTBIO CORP. SURGIPRO45

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male