BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIGEL INJECTABLE GEL

    MDR report key: 20293248 · Received September 24, 2024

    Report

    Report Number
    3014909464-2024-00018
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 6, 2024
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    OVB
    PMA / PMN Number
    K220641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

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

    Description of Event or Problem · 0

    ON 06-SEP-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [PHYSICIAN] IN THE UNITED STATES. IT WAS REPORTED THAT "DURING THE CASE (NO PALETTE REPRESENTATIVE PRESENT), THE [PHYSICIAN] FELT HE WAS NOT IN THE PERIRECTAL FAT AND THEN REDIRECTED THE NEEDLE AND PROCEEDED WITH THE IMPLANT. [PHYSICIAN] WAS HAPPY WITH THE FINAL IMPLANT BUT CONCERNED ABOUT HOW MUCH PRODUCT WAS INJECTED INTO THE INCORRECT SPACE. [PHYSICIAN] OBTAINED AN MR IMAGE AND CONFIRMED APPROXIMATELY 1CC OF BARRIGEL IN THE RECTAL WALL. THE PATIENT DID NOT REPORT ANY ISSUES POST-INJECTION. [PHYSICIAN] CONTACTED [PALETTE LIFE SCIENCES REPRESENTATIVE] TO INFORM OF HIS PLAN TO REVERSE THE INJECTION WITH HYALURONIDASE". [PHYSICIAN] USED HYLENEX FOR THE REVERSAL AND REPORTED THAT IT "WENT EXCELLENT". ADDITIONAL INFORMATION RECEIVED ON 16-SEP-2024 FROM THE IU PATIENT & PHYSICIAN SUPPORT TEAM INDICATED THAT "THIS RWI IS GRADE 2".

    Description of Event or Problem · 0

    ON (B)(6)2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [PHYSICIAN] IN THE UNITED STATES. IT WAS REPORTED THAT "DURING THE CASE (NO PALETTE REPRESENTATIVE PRESENT), THE [PHYSICIAN] FELT HE WAS NOT IN THE PERIRECTAL FAT AND THEN REDIRECTED THE NEEDLE AND PROCEEDED WITH THE IMPLANT. [PHYSICIAN] WAS HAPPY WITH THE FINAL IMPLANT BUT CONCERNED ABOUT HOW MUCH PRODUCT WAS INJECTED INTO THE INCORRECT SPACE. [PHYSICIAN] OBTAINED AN MR IMAGE AND CONFIRMED APPROXIMATELY 1CC OF BARRIGEL IN THE RECTAL WALL. THE PATIENT DID NOT REPORT ANY ISSUES POST-INJECTION. [PHYSICIAN] CONTACTED [PALETTE LIFE SCIENCES REPRESENTATIVE] TO INFORM OF HIS PLAN TO REVERSE THE INJECTION WITH HYALURONIDASE". [PHYSICIAN] USED HYLENEX FOR THE REVERSAL AND REPORTED THAT IT "WENT EXCELLENT". ADDITIONAL INFORMATION RECEIVED ON 16-SEP-2024 INDICATED THAT "THIS RWI IS GRADE 2".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105188 BARRIGEL INJECTABLE GEL HYDROGEL SPACER OVB PALETTE LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HYLENEX USED FOR REVERSAL, NO DATE PROVIDED.| HYLENEX USED FOR REVERSAL, NO DATE PROVIDED.