BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR 10ML

    MDR report key: 8091757 · Received November 20, 2018

    Report

    Report Number
    3008550999-2018-00011
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    April 1, 2018
    Report Date
    October 21, 2018
    Manufacturer
    AUGMENIX, INC
    Product Code
    OVB
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT TWO PATIENTS MAY HAVE DEVELOPED A FISTULA SEVERAL MONTHS AFTER SPACEOAR AND HDR TREATMENT FOR PROSTATE CANCER. IT WAS REPORTED THAT ONE PATIENT RECEIVED A TEMPORARY DIVERSION AND IS NOW HEALING. THE SECOND PATIENT HAS EXHIBITED SYMPTOMS OF A FISTULA AND THE MANAGEMENT OF HIS CARE IS CURRENTLY BEING EVALUATED. NO ADDITIONAL INFORMATION REGARDING THE PROCEDURE OR PATIENT HISTORY IS AVAILABLE AT THIS TIME. FROM THE AVAILABLE INFORMATION, THE CAUSE OF THE FISTULA IN THE FIRST PATIENT COULD NOT BE CONCLUSIVELY DETERMINED. INVESTIGATION INTO THE EXISTENCE OF A FISTULA IN THE SECOND PATIENT IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS MAY HAVE DEVELOPED A FISTULA SEVERAL MONTHS AFTER SPACEOAR AND HDR TREATMENT FOR PROSTATE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931058 SPACEOAR 10ML HYDROGEL SPACER OVB AUGMENIX, INC SO-2101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention