BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIATION 200GY TOTAL 6000GY

    MDR report key: 8202264 · Received December 26, 2018

    Report

    Report Number
    8202264
    Event Type
    Death
    Date Received
    December 26, 2018
    Date of Event
    December 2, 2018
    Report Date
    December 14, 2018
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT BEGAN TO HAVE A NOSE BLEED. AS PER FAMILY PT WAS INSTRUCTED TO GO TO ER IF DEVELOPED A NOSE BLEED. PT STARTED TO BLEED PROFUSELY AND FAMILY CALLED 911. BY THE TIME EMS ARRIVED AT THE SCENE, PT WAS LYING IN A POOL OF BLOOD AND WAS UNRESPONSIVE WITHOUT PULSE AND RESPIRATION. CPR STARTED, EMS WERE NOT ABLE TO RESUSCITATE THE PT. ACCORDING TO TREATING MD FROM AN OFFICE VISIT ON (B)(6) 2018, PT HAD A NON HEALING ULCERATION INVOLVING THE LEFT SOFT PALATE INVOLVING THE SUPERIOR PORTION OF THE TONSILLAR FOSSA AND THE SOFT PALATE ON THE LEFT SIDE. THIS CONSISTENT WITH LEFT-SIDE ULCERATION MOST LIKELY RELATED TO RADIATION. THERE IS A FUNGAL DEBRIS PRESENT. ON OFFICE VISIT FROM (B)(6) 2018, AUSCULTATION OF THE LEFT CAROTID DEMONSTRATED A BRUIT. EXAMINATION REVEALED AN ULCERATION EXTENDING FROM UPPER PORTION OF THE LEFT TONSILAR PILLAR TO HIS LATERAL PHARYNGEAL WALL INFERIORLY OVER A DISTANCE OF APPROX 2-3 CENTIMETERS. PALPITATION REVEALED NO EVIDENCE OF PULSATION IN THE DEPTHS OF THE ULCER. THIS CAROTID RUPTURE IF A RARE, BUT KNOWN SIDE EFFECT OF RT, AND THIS EVENT, DO NOT BELIEVE IT IS RELATED TO ALL WITH THE STUDY DRUG. THIS EVENT IS REPORTED AS BEING UNEXPECTED AS IT IS NOT IN THE IB.

    Description of Event or Problem · 1

    THIS CAROTID RUPTURE IS A RARE BUT KNOW SIDE EFFECT OF RADIATION, AND THIS EVENT IS NOT BELIEVED TO BE RELATED AT ALL TO THE STUDY DRUG. THIS EVENT IS BEING REPORTED AS UNEXPECTED AS IT IS NOT IN THE INFORMED CONSENT. OUR REGULATORY DEPT IS WORKING ON AMENDMENT TO ADD THIS TO OUR INFORMED CONSENT AS A RARE RISK BUT POSSIBLE OF THE RADIATION TREATMENT. IND# (B)(4). DIAGNOSED FOR USE: HEAD AND NECK CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034197 RADIATION 200GY TOTAL 6000GY RADIATION 200GY TOTAL 6000GY MUJ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death