BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 22052619 · Received May 20, 2025

    Report

    Report Number
    3014909464-2025-00021
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 7, 2025
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    PMA / PMN Number
    K220641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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

    ON APRIL 24, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM THE US. IT WAS REPORTED THAT "THIS WAS A 10 CC RWI WHICH OCCURRED." ADDITIONAL INFORMATION RECEIVED ON APRIL 29, 2025, INDICATED THAT "THE PATIENT IS CURRENTLY ASYMPTOMATIC, AND A CALL IS SCHEDULED WITH PALETTE LIFE SCIENCES REPRESENTATIVE AND PHYSICIANS TO DISCUSS THE REVERSAL WITH HYALURONIDASE." FURTHER ADDITIONAL INFORMATION RECEIVED ON MAY 07, 2025, MENTIONED THAT "THE REVERSAL PROCEDURE OCCURRED TODAY, ON (B)(6) 2025, THE LARGE AREA OF RECTAL WALL INFILTRATION (RWI) WAS NOT VISUALIZED BUT A SMALLER AREA WAS INJECTED WITH 0.5 CC OF HYALURONIDASE."

    Description of Event or Problem · 0

    ON APRIL 24, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM THE US. IT WAS REPORTED THAT "THIS WAS A 10 CC RWI WHICH OCCURRED." ADDITIONAL INFORMATION RECEIVED ON APRIL 29, 2025, INDICATED THAT "THE PATIENT IS CURRENTLY ASYMPTOMATIC, AND A CALL IS SCHEDULED WITH PALETTE LIFE SCIENCES REPRESENTATIVE AND PHYSICIANS TO DISCUSS THE REVERSAL WITH HYALURONIDASE." FURTHER ADDITIONAL INFORMATION RECEIVED ON MAY 07, 2025, MENTIONED THAT "THE REVERSAL PROCEDURE OCCURRED TODAY, (B)(6) 2025, THE LARGE AREA OF RECTAL WALL INFILTRATION (RWI) WAS NOT VISUALIZED BUT A SMALLER AREA WAS INJECTED WITH 0.5 CC OF HYALURONIDASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033227 BARRIGEL INJECTABLE GEL HYDROGEL SPACER OVB PALETTE LIFE SCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.