BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 13977798 · Received April 1, 2022

    Report

    Report Number
    9611053-2022-00516
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Report Date
    May 18, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT WST 6:1 F. VDW.GOLD/SILVER CONTRA ANGLE WON'T HOLD FILES. NO INFORMATION REGARDING INJURY. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. CONTRA ANGLE WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18930 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