BEUDAMED
    FDA Adverse Event Summary report: N

    MCLAREN PROTON THERAPY SYSTEM

    MDR report key: 11108282 · Received December 31, 2020

    Report

    Report Number
    MW5098638
    Date Received
    December 31, 2020
    Report Date
    December 29, 2020
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE MCLAREN PROTON THERAPY SYSTEM DELIVERED AN INCORRECT DOSE TO THE PATIENT THAN PRESCRIBED DUE TO AN ERROR IN THE SOFTWARE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567874 MCLAREN PROTON THERAPY SYSTEM SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN MCLAREN HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1