BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEREOTACTIC BODY RADIATION THERAPY (SBRT)

    MDR report key: 22348825 · Received June 26, 2025

    Report

    Report Number
    MW5172066
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    June 22, 2025
    Report Date
    June 23, 2025
    Manufacturer
    UNKNOWN
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH HIGH-GRADE UROTHELIAL CARCINOMA COMPLETED 3 CYCLES OF ENFORTUMAB VEDOTIN ON (B)(6) 2025 AND STEREOTACTIC RADIATION THERAPY (3250 CGY/5 FRACTIONS) (B)(6) 2025, SUBSEQUENTLY UNDERWENT A ROBOTIC-ASSISTED CYSTECTOMY WITH THE CREATION OF AN ILEAL CONDUIT ON (B)(6) 2025 AND WAS DISCHARGED ON (B)(6) 2025. UPON RETURNING HOME, THE PATIENT HAD A DIMINISHED APPETITE, CONSUMING ONLY A FEW BITES OF FOOD AND A GLASS OF WATER. SHE EXPERIENCED NAUSEA AFTER TAKING A PAIN PILL, WHICH SHE VOMITED UP APPROXIMATELY 15 MINUTES LATER (3:15). SHE THEN VOMITED ANOTHER 15 MIN (3:30). SHE REPORTS NO BOWEL MOVEMENTS SINCE (B)(6) 2025. SHE HAS STARTED TO PASS A LITTLE GAS WHILE IN THE EMERGENCY DEPARTMENT. SHE HAS NOT TAKEN ANY BOWEL REGIMEN SINCE DISCHARGE ON (B)(6) 2025. DUE TO HER BENIGN EXAM AND LACK OF LARGE GASTRIC BUBBLE ON IMAGING TODAY, EMESIS LIKELY 2/2 TO TAKING PAIN MEDICATION ON AN EMPTY STOMACH. BREAST CANCER IN 2000 TREATED WITH CHEMOTHERAPY (SHE REPORTS 6 CYCLES OF ADRIAMYCIN CYTOXAN) AND LEFT MASTECTOMY AND EVENTUAL RIGHT MASTECTOMY LAP RECONSTRUCTION AND BILATERAL SALPINGO OOPHORECTOMY FOR BRCA POSITIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262408 STEREOTACTIC BODY RADIATION THERAPY (SBRT) ACCELERATOR, LINEAR, MEDICAL IYE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization ENFORTUMAB VEDOTIN.