BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 3687400 · Received March 11, 2014

    Report

    Report Number
    8022247-2014-00003
    Event Type
    Injury
    Date Received
    March 11, 2014
    Date of Event
    February 3, 2014
    Report Date
    March 11, 2014
    Manufacturer
    NORDION (CANADA) INC
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NECROSIS OF STOMACH, GALLBLADDER AND DUODENUM WAS PROBABLY RELATED TO DELIVERY OF THERASPHERE TO EXTRAHEPATIC VESSELS. NO ADD'L ACTIONS RECOMMENDED AT THIS TIME. ADD'L INFO REGARDING SURGERY AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE PT RECEIVED THERASPHERE TREATMENT AT (B)(6), ON THE (B)(6) 2014, RECEIVING A 3.5 AND A 7 GBQ DOSE TO THE LEFT LOBE. NO FURTHER INFO FOR PT'S MEDICAL HISTORY OR TREATMENT IS AVAILABLE AT PRESENT. ONE WEEK AFTER THE TREATMENT, THE PT WENT TO (B)(6). SHE HAD SOME NECROSIS AT STOMACH, GALLBLADDER AND DUODENUM. SHE HAD SURGERY ON THE (B)(6). ADD'L INFO REGARDING SURGERY AND OUTCOME HAS BEEN REQUESTED. DR (B)(6) FIRST GOT IN TOUCH WITH THE DISTRIBUTOR (B)(4) TO CHECK IF ANY ADD'L PROTECTION IS REQUIRED DURING THE SURGERY AND THEY CONTACTED THE (B)(6) FOR MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145959 THERASPHERE YTTRIUM-90 MICROSPHERES NAW NORDION (CANADA) INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R