BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US BARRIGEL (3ML)

    MDR report key: 24405247 · Received February 20, 2026

    Report

    Report Number
    3014909464-2026-00008
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 26, 2026
    Report Date
    January 26, 2026
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    PMA / PMN Number
    K220641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. OTHER REMARKS: N/A CORRECTED DATA: N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "MY PARTNER HAD THAT PROCEDURE AND ENDED UP IN THE HOSPITAL FOR A WEEK DUE TO TWO ABSCESS'S AND A TERRIBLE BLOOD INFECTION." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460985 US BARRIGEL (3ML) HYDROGEL SPACER OVB PALETTE LIFE SCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.