BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY EXCAVATOR (SUSPECTED)

    MDR report key: 5051684 · Received September 2, 2015

    Report

    Report Number
    1416605-2015-00004
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    June 10, 2015
    Report Date
    September 2, 2015
    Manufacturer
    HU-FRIEDY MFG CO., LLC
    Product Code
    EKC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT NOT RETURNED FOR EVALUATION. UNABLE TO VERIFY INSTRUMENT CATALOG NUMBER AND MANUFACTURING DATE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6), DURING A DENTAL PROCEDURE, THE INSTRUMENT TIP BROKE AND WAS SWALLOWED BY PATIENT. A LOCAL ANESTHETIC WAS BEING USED AT THE TIME OF THE PROCEDURE. PATIENT WAS SENT TO THE ER FOR X-RAYS AND SCOPING PROCEDURE. X-RAYS SHOWED TIP WENT INTO THE STOMACH BUT WAS UNABLE TO BE FOUND DURING SCOPING PROCEDURE. ON (B)(6), ANOTHER X-RAY WAS TAKEN AND SHOWED TIP HAD MOVED DOWN INTO THE LARGE INTESTINE. ON (B)(6), THE TIP HAD BEEN REMOVED VIA ENDOSCOPIC PROCEDURE. ON (B)(6), DOCTOR REPORTED HE SAW PATIENT AGAIN FOR ANOTHER TOOTH AND PATIENT WILL ALSO BE GETTING AN MRI DUE TO PAIN IN HIS LOWER GUT AREA WHERE TIP WAS PREVIOUSLY LODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581416 HU-FRIEDY EXCAVATOR (SUSPECTED) EXCAVATOR EKC HU-FRIEDY MFG CO., LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization