BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIATION

    MDR report key: 4270324 · Received November 13, 2014

    Report

    Report Number
    MW5039151
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 6, 2014
    Product Code
    KPQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PEG TUBE PLACEMENT FOR GRADE 3 ORAL PAIN UNLIKELY RELATED TO THE AGENT. EVENT TOOK PLACE DURING CYCLE 6. SUSPECT PRODUCT: RADIATION. DOSE FREQUENCY & ROUTE USED: 6000 CGY. THERAPY DATES: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732156 RADIATION RADIATION KPQ

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other THERAPY DATES: (B)(6) 2014| N-ACETYLCYSTEINE, 25 ML,