BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLESTA INJECTABLE GEL

    MDR report key: 21569175 · Received March 10, 2025

    Report

    Report Number
    3014909464-2025-00008
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    ON FEBRUARY 14, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A NURSE IN THE UNITED STATES. IT WAS REPORTED THAT "WHEN PALETTE LIFE SCIENCES REPRESENTATIVE AND THE NURSE WERE ASSEMBLING THE SYRINGE, IT BROKE AND CAME APART. THEY HAVE TO OPEN UP ANOTHER KIT."

    Description of Event or Problem · 0

    ON FEBRUARY 14, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A NURSE IN THE UNITED STATES. IT WAS REPORTED THAT "WHEN PALETTE LIFE SCIENCES REPRESENTATIVE AND THE NURSE WERE ASSEMBLING THE SYRINGE, IT BROKE AND CAME APART. THEY HAVE TO OPEN UP ANOTHER KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082245 SOLESTA INJECTABLE GEL AGENT, BULKING, INJECTABLE FOR GASTR LNM PALETTE LIFE SCIENCES 20934

    Patients

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