BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROPSHERES

    MDR report key: 7875700 · Received September 13, 2018

    Report

    Report Number
    9710358-2018-00001
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    January 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH COMPLICATED ANATOMY RECEIVED SIRT TREATMENT. DESPITE DIFFICULTY ANATOMY, DOSE WAS ABLE TO BE DELIVERED AND EVERYTHING WAS THOUGHT TO BE ALRIGHT. PATIENT HAD ONGOING PAIN SEVERAL WEEKS OUT AND WAS REFERRED TO THE GI GROUP WHO PERFORMED AN ENDOSCOPY. DIAGNOSIS WAS ULCERATIVE GASTRITIS OF THE ESOPHAGUS. PATIENT WAS TREATED BY THE GI TEAM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713014 SIR-SPHERES MICROPSHERES YTTRIUM 90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other