BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNEA

    MDR report key: 7240903 · Received February 5, 2018

    Report

    Report Number
    3015729-2018-00002
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    January 8, 2018
    Report Date
    February 5, 2018
    Manufacturer
    W&HDENTALWEK
    Product Code
    EFB
    PMA / PMN Number
    K993526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF A ROUTINE DENTAL EXAMINATION, A BUR FELL OUT OF A WG-99LT INTO A PATIENTS MOUTH AND WAS SWALLOWED. THE HEADPEICE SPUN OUTSIDE OF THE MOUTH FINE, BUT WHEN IT TOUCHED THE TOOTH THE BUR FELL OUT AND WAS SWALLOWED BY THE PATIENT. THE PATIENT HAD TO GO TO HOSPITAL AND HAVE THE BUR REMOVED WITH ENDOSCOPY WITH NO ADDITIONAL ISSUES. THE HANDPIECE HAS BEEN RETURNED FOR EVALUATION: THE HANDPIECE IS CLEAN AND IN GOOD CONDITION. THE CHUCKING MECHANISM WAS TESTED WITH SEVERAL CHUCK TOOLS AND NO ISSUES WERE FOUND. GEARS AND BEARINGS ARE FREE OF ANY DEBRIS. LOT NUMBER INDICATES CHUCK MECHANISM (643), ATTACHMENT RAN FOR SEVERAL MINUTES WITH NOTICABLE TEMPERATURE CHANGE IN THE HEAD WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84269 SYNEA HIGH SPEED HANDPIECE EFB W&HDENTALWEK WG-99LT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention