BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIGEL

    MDR report key: 24876049 · Received April 14, 2026

    Report

    Report Number
    3014909464-2026-00034
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 19, 2026
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE FOR ANALYSIS. ALL LOTS OF BARRIGEL ARE RELEASED BY BOTH GALDERMA/Q-MED (CONTRACT MANUFACTURER) AND PALETTE LIFE SCIENCES (LEGAL MANUFACTURER). BOTH RELEASES ENSURE THAT THE PRODUCT'S PREDETERMINED SPECIFICATIONS, AS NOTED IN THE RELEVANT PALETTE PART SPECIFICATIONS, ARE MET AND THAT THERE ARE NO CRITICAL DEVIATIONS ASSOCIATED WITH THE REVIEWED LOTS. WITHOUT THE DEVICE TO EVALUATE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "SOME GEL MAY HAVE GOTTEN INTO THE VENOUS PLEXUS AND A LITTLE TO THE RIGHT INTERNAL ILIAC VEIN. FINDINGS CONSISTENT WITH INTRAVASATION OF SPACER GEL INTO THE PERIPROSTATIC VENOUS PLEXUS ON THE RIGHT SIDE AND EXTENSION INTO A RIGHT INTERNAL ILIAC VEIN TRIBUTARY ALONG THE PELVIC SIDEWALL." ADDITIONAL INFORMATION RECEIVED ON MARCH 24, 2026, INDICATED THAT "THE PHYSICIAN PERFORMED A FULL ANGIO WORKUP WITH CT AND CONFIRMED THERE WAS NO EXTENSION INTO THE COMMON ILIAC VEIN AND NO PULMONARY EMBOLUS. THE PATIENT IS ASYMPTOMATIC AND WAS PRESCRIBED 81 MG ASPIRIN WITH NO ADDITIONAL TREATMENT. THE PHYSICIAN WAS NOT INTERESTED IN SPEAKING WITH OUR FACULTY PHYSICIANS AS HE WOULDN'T CHANGE HIS TREATMENT PLAN BASED ON RESEARCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940264 BARRIGEL HYDROGEL SPACER OVB PALETTE LIFE SCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.