BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 20536378 · Received October 25, 2024

    Report

    Report Number
    3014909464-2024-00035
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 29, 2024
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    PMA / PMN Number
    K220641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) N/A OTHER REMARKS: N/A CORRECTED DATA: N/A

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. PALETTE LIFE SCIENCES WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A PALETTE REPRESENTATIVE WHO RECEIVED IT FROM A [PHYSICIAN] IN THE UNITED STATES, REPORTING THAT "THE [PHYSICIAN] CASE WAS ON (B)(6) 2024. I LEARNED ABOUT RECTAL WALL INFILTRATION (RWI) ON (B)(6). MET PATIENT IN (B)(6) AND GAVE HIM CHOICE TO PROCEED OR NOT WITH REVERSAL. THE HAS (HYALURONIDASE) REVERSAL PROCEDURE WILL BE DONE THIS FRIDAY, ON (B)(6) 2024."

    Description of Event or Problem · 0

    ON OCTOBER 23, 2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A PALETTE REPRESENTATIVE WHO RECEIVED IT FROM A [PHYSICIAN] IN THE UNITED STATES, REPORTING THAT "THE [PHYSICIAN] CASE WAS ON (B)(6) 2024. I LEARNED ABOUT RECTAL WALL INFILTRATION (RWI) ON (B)(6) MET PATIENT IN AUGUST AND GAVE HIM CHOICE TO PROCEED OR NOT WITH REVERSAL. THE HAS (HYALURONIDASE) REVERSAL PROCEDURE WILL BE DONE THIS FRIDAY, (B)(6) 2024."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945434 BARRIGEL INJECTABLE GEL BARRIGEL / HYDROGEL SPACER OVB PALETTE LIFE SCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NONE REPORTED.| NONE REPORTED.