BEUDAMED
    FDA Adverse Event Summary report: N

    MCLAREN PROTON THERAPY

    MDR report key: 11384965 · Received February 25, 2021

    Report

    Report Number
    MW5099650
    Date Received
    February 25, 2021
    Report Date
    February 23, 2021
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MCLAREN PROTON THERAPY SYSTEM COLLIDED WITH THE DELIVERY NOZZLE DURING PATIENT IMAGING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273783 MCLAREN PROTON THERAPY SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN MCLAREN HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1