BEUDAMED
    FDA Adverse Event Other Summary report: N

    W&H TA-97LED PLUS

    MDR report key: 3204222 · Received June 25, 2013

    Report

    Report Number
    3015729-2013-00003
    Event Type
    Other
    Date Received
    June 25, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 24, 2013
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K070663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD INPUT REPORT (FIR) NUMBER: (B)(4). PRODUCT QUALITY REPORT (PQR) NUMBER: (B)(4).

    Description of Event or Problem · 1

    OFFICE REPORTED "BURS FLYING OUT MORE THAN ONCE, PATIENT SWALLOWED ONE." SUBSEQUENT CALL TO OFFICE FOR INVESTIGATION REVEALED PATIENT WAS REFERRED TO EMERGENCY ROOM FOR TREATMENT. AFTER CONFIRMATORY RADIOLOGY, BUR WAS EXTRICATED FROM PATIENT'S STOMACH BY MEANS OF AN ENDOSCOPE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288078 W&H TA-97LED PLUS DENTAL HIGH-SPEED HANDPIECE (PNEUMATIC) EFB W&H DENTALWERK BUERMOOS GMBH TA-97LED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention