BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACK SCALER

    MDR report key: 9665595 · Received February 3, 2020

    Report

    Report Number
    MW5092728
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 30, 2020
    Report Date
    January 30, 2020
    Manufacturer
    PDT, INC.
    Product Code
    EMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CATASTROPHIC INSTRUMENT FAILURE OF APPROXIMATELY 20-30 INSTRUMENTS, PURCHASED SINCE 2018. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123663 JACK SCALER SCALER, PERIODONTIC EMN PDT, INC. R138

    Patients

    Seq Age Sex Outcome Treatment
    1