BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 17831191 · Received September 28, 2023

    Report

    Report Number
    3014909464-2023-00003
    Event Type
    Death
    Date Received
    September 28, 2023
    Date of Event
    September 15, 2023
    Report Date
    September 27, 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

    Additional Manufacturer Narrative · 0

    AT TIME OF FOLLOW-UP, NO CAUSAL LINK ESTABLISHED BETWEEN THE PATIENT DEATH AND USE OF BARRIGEL. PHYSICIAN FELT THAT DEATH WAS DUE TO PULMONARY EMBOLISM (UNCONFIRMED) AND NOT RELATED TO BARRIGEL OR THE INJECTION PROCEDURE.

    Additional Manufacturer Narrative · 0

    AT TIME OF FOLLOW-UP, NO CAUSAL LINK ESTABLISHED BETWEEN THE PATIENT DEATH AND USE OF BARRIGEL. PHYSICIAN FELT THAT DEATH WAS DUE TO PULMONARY EMBOLISM (UNCONFIRMED) AND NOT RELATED TO BARRIGEL OR THE INJECTION PROCEDURE.

    Additional Manufacturer Narrative · 0

    AT TIME OF REPORT, NO CAUSAL LINK ESTABLISHED BETWEEN PATIENT DEATH AND USE OF BARRIGEL.

    Description of Event or Problem · 0

    3 DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKER PLACEMENT AND BARRIGEL INSERTION, PATIENT PASSED AWAY AT HOME. DETERMINATION OF CAUSE OF DEATH IN-PROCESS.

    Description of Event or Problem · 0

    THREE DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKER PLACEMENT AND BARRIGEL INSERTION, PATIENT PASSED AWAY AT HOME. DETERMINATION OF CAUSE OF DEATH IN-PROCESS.

    Description of Event or Problem · 0

    3 DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKER PLACEMENT AND BARRIGEL INSERTION, PATIENT PASSED AWAY AT HOME. DETERMINATION OF CAUSE OF DEATH IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971336 BARRIGEL INJECTABLE GEL BARRIGEL OVB PALETTE LIFE SCIENCES 011508 00850004725108

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death