BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCLAREN PROTON THERAPY SYSTEM

    MDR report key: 11036698 · Received December 17, 2020

    Report

    Report Number
    MW5098439
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PROTON THERAPY SYSTEM SELECTED A WRONG TREATMENT DELIVERY FIELD AND DELIVERED AN INCORRECT DOSE TO THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498931 MCLAREN PROTON THERAPY SYSTEM SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN MCLAREN HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1