BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTG AUTOCL PROPHY ANG.

    MDR report key: 4360409 · Received December 19, 2014

    Report

    Report Number
    2523190-2014-00072
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Report Date
    November 26, 2014
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EAX
    PMA / PMN Number
    K073652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DOCTOR REPORTS THEY DID NOT OIL THE DEVICE BEFORE THIS EVENT OCCURRED. BLACKISH DEBRIS OCCURS INTERMITTENTLY SINCE DEVICE WAS NEW IN OCTOBER. WHEN TEETH ARE BEING CLEANED AND THE DEVICE COMES IN CONTACT WITH SALIVA AND BLACK APPEARS. SEEMS TO BE COMING FROM AREA WHERE THE DISPOSABLE CUP ATTACHES. NO PATIENT HARM. WHEN THEY RUN DEVICE IN WATER NO BLACK MATERIAL OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837802 VANTG AUTOCL PROPHY ANG. M52- HYGIENE / PERIDONTAL EAX INTEGRA YORK, PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1