BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 13929086 · Received March 28, 2022

    Report

    Report Number
    9611053-2022-00513
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Report Date
    May 11, 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. 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

    CONTRA ANGLE 151147 (2021) (HEAVILY SOILED MUST BE CLEANED AND OILED) DEFECTIVE, REPAIRED. THE HOUSING HAS BROKEN IN SEVERAL PLACES (PROBABLY DUE TO A FALL) HAS NO EFFECT ON THE FUNCTION. MICROMOTOR GMR2191211 (SCRATCHED), FOOT CONTROL 198276, MEASURING CABLE LIP CLIP, MOTOR CABLE (SCRATCHED AND STIFF) AND CHARGER HAVE NO FAULTS. SENT WITHOUT MEASURING CABLE FILE CLAMP.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A CONTRA ANGLE 6:1 VDW GOLD/SILVER WON'T HOLD FILES. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14337 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