BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 17873497 · Received October 4, 2023

    Report

    Report Number
    3014909464-2023-00004
    Event Type
    Death
    Date Received
    October 4, 2023
    Date of Event
    September 15, 2023
    Report Date
    October 4, 2023
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    UDI-DI
    00850004725108
    PMA / PMN Number
    K22641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    3 DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKET PLACEMENT AND INJECTION OF BARRIGEL PATIENT PASSED AWAY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352412 BARRIGEL INJECTABLE GEL BARRIGEL OVB PALETTE LIFE SCIENCES 011508 00850004725108

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death