BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 8596248 · Received May 9, 2019

    Report

    Report Number
    9611053-2019-00119
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY (B)(4). SM10796 (OIL INSIDE MOTOR) DEFECT, REPLACED WITH SM 42374. FOOT PEDAL SOCKET (BROKEN) DEFECT, REPLACED. WITHOUT CHARGING UNIT. CONTRA ANGLE 11668 (2008) AND FOOT CONTROL 111008 WITHOUT ERROR. GENERAL CHECK WITHOUT ERROR.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED SPEED INCORRECT/TOO FAST/TOO SLOW FOR AN VDW. SILVER; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389040 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1