BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SBRT

    MDR report key: 11562608 · Received March 23, 2021

    Report

    Report Number
    MW5100232
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 20, 2021
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY STAFF WERE NOTIFIED OF THE EVENT ON (B)(6) 2021 INITIAL SUBMISSION DATE OF THE REPORT 3/20/2021. SUBJECT (B)(6) IS A (B)(6) YEAR-OLD FEMALE WITH CERVICAL CANCER WHO INITIATED TREATMENT ON (B)(6) ON (B)(6) 2021. THE SUBJECT IS CURRENTLY IN WEEK 10 RECEIVING A TOTAL OF: 1 DOSE OF ATEZOLIZUMAB OF 1200 MG IN 20 ML WITH HER MOST RECENT DOSE ON (B)(6) 2021 AND 3 FRACTIONS OF SBRT 1100 CGY ON (B)(6) 2021. PATIENT (B)(6) PRESENTED TO (B)(6) CANCER CENTER'S URGENT CARE ON (B)(6) 2021 WITH COMPLAINTS OF ABDOMINAL PAIN, DIFFICULTY WALKING, AND SEVERE WEAKNESS. THE PATIENT ALSO COMPLAINED OF MILD BACK PAIN. PER URGENT CARE NOTE, PATIENT HAS EXTENSIVE EDEMA TO BOTH LE'S WITH +3 PITTING EDEMA. CBC/ CMP DEEMED OVERALL UNREMARKABLE HOWEVER, LIPASE 61 U/L AND LACTIC ACID 1.8 MMOL/L NOTED. PATIENT (B)(6) HGB HAS REMAINED CONSISTENTLY LOW AT 8.6 G/DL AT TIME OF ADMISSION. LASIX WAS ORDERED WITH KCI. MRI SPINE ORDERED ON (B)(6) 2021 SHOWED NO EVIDENCE OF BONY METASTATIC DISEASE INVOLVING THE LUMBAR SPINE. XRAY OF THE ABDOMEN ON (B)(6) 2021 STATED UNREMARKABLE ABDOMINAL GAS PATTERN WITH THE LEFT URETERAL STENT IN A SATISFACTORY RADIOGRAPHIC POSITION. PATIENT TO FOLLOW UP WITH OT/PT WITH CONCERNS OF A FALL RISK. RECOMMENDED CONSULTS FOR PAIN MANAGEMENT AND SUPPORTIVE CARE AS WELL. THIS SAE WILL BE FOLLOWED UP WITH WHEN MORE RECORDS ARE AVAILABLE. GRADE 2 - ANEMIA AND EDEMA LIMBS. PER PL AND TREATING, UNRELATED TO PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445558 SBRT SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization