BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRONOVA SC360

    MDR report key: 14460825 · Received May 20, 2022

    Report

    Report Number
    3010726836-2022-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    March 24, 2022
    Manufacturer
    PRONOVA SOLUTIONS, LLC
    Product Code
    LHN
    UDI-DI
    0086327400318
    PMA / PMN Number
    K162246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FIRST REPORTING, AND WE HAD ISSUES AND UNFORTUNATELY IT IS LATE. WE HAD ISSUES SETTING UP OUR ESG PRODUCTION ACCOUNT. OUR TEST ACCOUNT WAS APPROVED ON (B)(6) 2022 BUT OUR PRODUCTION ACCOUNT WAS NOT APPROVED UNTIL (B)(6) 2022. WE WORKED WITH THE ESG HELP DESK FROM THE BEGINNING AND THROUGHOUT UNTIL THE ISSUE WAS RESOLVED AND OUR PRODUCTION ACCOUNT WAS ESTABLISHED.

    Description of Event or Problem · 0

    A COSMETIC COVER FELL OFF OF THE NOZZLE DURING TREATMENT. THE COVER DID NOT HIT ANYONE, IT LANDED ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658760 PRONOVA SC360 PROTON THERAPY SYSTEM LHN PRONOVA SOLUTIONS, LLC SC360 0086327400318

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male