BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIATION

    MDR report key: 3888967 · Received June 16, 2014

    Report

    Report Number
    MW5036726
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 16, 2014
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MUCOSITIS - GRADE 3 ATTRIBUTION: DEFINITE. ORAL PAIN - GRADE 3 ATTRIBUTION: DEFINITE. RADIATION DERMATITIS GRADE 3 ATTRIBUTION: DEFINITE. PT PRESENTED TO HOSPITAL AFTER 2 WEEKS OF RADIATION TREATMENT AND TREATMENT WITH DOCETAXEL, WITH ORAL CAVITY PAIN AND BLISTER FORMATION ON FACE, NECK AND UPPER CHEST. PT WAS STARTED ON MORPHINE PCA WITH BASAL RATE OF 1.5 MG PER HOUR AND BOLUS RATE 0.4 Q 15 MIN. (B)(6) CREAM WAS USED FOR BLISTERS. PT REPORTED RELIEF IN PAIN AND WAS ABLE TO TAKE IN MORE LIQUIDS. HE WAS SWITCHED TO OXYCONTIN 40 MG BID AND OXYCODONE 10 MG Q 6 HOURS AS NEEDED. HE WAS ALSO CONTINUED (B)(6) 2014. DOSE, FREQUENCY & ROUTE USED: 1.5 GY BID DAY 1-12, THERAPY DATES (B)(6) 2014; 30MG DAYS 1 & 8, (B)(6) 2014. DIAGNOSIS FOR USE: SQUAMOUS CELL OF LEFT TONSIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353378 RADIATION MUJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization DOCETAXEL