BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA INJECTABLE GEL

    MDR report key: 23710120 · Received December 3, 2025

    Report

    Report Number
    3014909464-2025-00064
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 6, 2025
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 SOLESTA 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 "UNFORTUNATELY, THE FIRST SOLESTA PATIENT ENDED UP HAVING DRAINAGE OF AN ABSCESS BY A COLORECTAL SURGEON". MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863855 SOLESTA INJECTABLE GEL AGENT, BULKING, INJECTABLE LNM PALETTE LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.