BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 14698514 · Received June 15, 2022

    Report

    Report Number
    9611053-2022-00567
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Report Date
    June 30, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. AFTER INSPECTION FOUND: BATTERY (VOLTAGE COLLAPSES UNDER LOAD) DEFECTIVE. MICROMOTOR GMR 112138 AND ANGLE PIECE 143992 (2020) (HEAVILY SOILED / COLLET DEFECTIVE) CANNOT BE SEPARATED, DEFECTIVE. FOOT CONTROL 189206, MEASURING CABLE SET AND POWER SUPPLY CHECKED, WITHOUT ERRORS.

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED INFORMATION THAT PATIENT WAS NOT INJURED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT VDW GOLD/SILVER WON'T HOLD FILES AND NOT POSSIBLE TO REMOVE HANDPIECE FROM CONTRA ANGLE. OUTCOME OF PATIENT INJURY IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628129 WST 6:1 F. VDW.GOLD/SILVER HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown