BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 19595666 · Received June 24, 2024

    Report

    Report Number
    3014909464-2024-00006
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    March 22, 2024
    Report Date
    May 6, 2024
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    PMA / PMN Number
    K220641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PROVIDED FROM COMPLAINANT. (B)(4). 20223-1

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: ROVIDED FROM COMPLAINANT.QN#(B)(4). WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. PALETTE LIFE SCIENCES WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. UDI#: (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: SECTION G, PMA/510(K)#, CORRECTED FROM "K22641" TO "K220641".

    Description of Event or Problem · 0

    ON 06-MAY-2024 PALETTE LIFE SCIENCES RECEIVED THE FOLLOWING REPORT FROM A [PHYSICIAN] IN AUSTRALIA "THE PATIENT HAD PERI URETHRAL BARRI GEL PLACEMENT. AFTER THE GOLD SEEDS AND BARRI GEL WERE IMPLANTED, THE PATIENT WENT INTO RETENTION AND NEEDED CATHETERIZING." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAS BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. THE PATIENT'S CONDITION IS UNKNOWN.

    Description of Event or Problem · 0

    ON 06-MAY-2024 PALETTE LIFE SCIENCES RECEIVED THE FOLLOWING REPORT FROM A [PHYSCIAN] IN AUSTRALIA "THE PATIENT HAD PERI URETHRAL BARRIGEL PLACEMENT. AFTER THE GOLD SEEDS AND BARRIGEL WERE IMPLANTED, THE PATIENT WENT INTO RETENTION AND NEEDED CATHETERIZING." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAS BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511651 BARRIGEL INJECTABLE GEL BARRIGEL OVB PALETTE LIFE SCIENCES 20223-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male GOLD SEEDS (FIDUCIAL MARKERS) IMPLANTED, NO DATE P.| GOLD SEEDS (FIDUCIAL MARKERS) IMPLANTED, NO DATE P.