BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PIEZO P2K

    MDR report key: 15084949 · Received July 22, 2022

    Report

    Report Number
    MW5111049
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    July 21, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MECTRON S.P.A.
    Product Code
    JDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DOCTOR SAYS THAT WHILE WORKING, THE SCALER HANDPIECE AND TIP GENERATE A KIND OF "POWER SURGE" FLOW, BUT THIS IS NOT RELATED TO THE EFFECTIVENESS OF BREAKING UP TARTAR DEPOSITS. THE DISCOMFORT IS REPORTED BY THE OPERATOR'S DOCTOR (UNCOMFORTABLE FEELING IN THE HAND) AND THE PATIENT'S PAIN. THE CLIENT WORKS ONLY WITH ORIGINAL TIPS. THE PROBLEM WITH THE SCALER WAS REPORTED BY THE DOCTOR FROM THE VERY BEGINNING OF THE INSTALLATION OF THE SCALER IN THE UNIT. THE SCALER INSTALLATIONS WERE CHECKED BY THE AUTHORIZED UNIT SERVICE SEVERAL TIMES. FOR MORE INFORMATION TO THE MECTRON TEST REPORT (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566116 COMPACT PIEZO P2K INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT JDX MECTRON S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female