BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXR PLASMA WORK STATION

    MDR report key: 22410931 · Received July 7, 2025

    Report

    Report Number
    MW5172226
    Event Type
    Injury
    Date Received
    July 7, 2025
    Report Date
    July 2, 2025
    Manufacturer
    GMV S.R.L.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTER IS A FORMER EMPLOYEE OF THE COMPANY AND WOULD LIKE TO REPORT ON THE MANUFACTURER THAT THEY FALSELY ADVERTISE ABOUT THE DEVICE AND THAT THE DEVICE IS FDA APPROVED RATHER THAN FDA CLEARED. THERE IS ONLY 1 SENTENCE IN THE 501K APPROVAL. THE FDA NEED TO TEST THE SAFETY AND EFFICACY OF THE DEVICE. THE REPORTER HIMSELF HAD ADVERSE EVENT WITH THE DEVICE LIKE SCARRING, EXTREME PAIN, DISCOLORATION, AND DAMAGED SKIN. HE WAS ASKED TO SELL THE PRODUCTS AND GAVE HIM FALSE SALES PITCHES. HE STATES THAT THE DEVICE IS A VERY DANGEROUS AND NEED TO BE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152576 PLEXR PLASMA WORK STATION ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GMV S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other