BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVERSE REACTION

    MDR report key: 11566143 · Received March 24, 2021

    Report

    Report Number
    9710358-2021-00001
    Event Type
    Death
    Date Received
    March 24, 2021
    Date of Event
    October 1, 2020
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS ON ADDITIONAL MEDICATION FOR BREAST CANCER TREATMENT INCLUDING, PALBOCICLIB, FASLODEX AND XGEVA. REFER TO DR. (B)(6) INITIAL ASSESSMENT.

    Description of Event or Problem · 1

    PATIENT INITIALS: (B)(6). AGE: (B)(6). PATIENT COMPLAINED OF SEVERE "BURNING ABDOMINAL PAIN IMMEDIATELY AFTER DOSE ADMINISTRATION (RIGHT LOBE ONLY TREATMENT). RESUMED PALBOCICLIB 8 DAYS AFTER. THIS RESOLVED SOMEWHAT AND FOR 2 MONTHS, SHE REPORTED VAGUE ABDOMINAL PAIN AND BLOATING WITH ELEVATED, BUT STABLE LFTS. SUBSEQUENTLY, IN MID-(B)(6) SHE DEVELOPED DARK URINE , ABDOMINAL PLAIN, BLOATING AND ICTERUS. BILIRUBIN AS WELL AS OTHER LIVER ENZYMES ALL SEVERELY ELEVATED. WAS ALSO COVID-19 POSITIVE. CT IMAGES SUGGESTED DEVELOPMENT OF ASCITES AND DEVELOPMENT OF PSEUDOCIRRHOSIS. DEVELOPED ASCITES WHICH REQUIRED PARACENTESIS. PATIENT DECLINED QUICKLY, WENT ON HOSPICE AND SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456246 ADVERSE REACTION SIR-SPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death