BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLESTA INJECTABLE GEL

    MDR report key: 21474579 · Received February 26, 2025

    Report

    Report Number
    3014909464-2025-00006
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    ON FEBRUARY 06 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [PHYSICIAN] IN THE UNITED STATES. IT WAS REPORTED THAT "THE NEEDLE HUB ON THE SYRINGE STARTED TO LEAK AND THEN BROKE OFF DURING THE INJECTION."

    Description of Event or Problem · 0

    ON (B)(6) PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [PHYSICIAN] IN THE UNITED STATES. IT WAS REPORTED THAT "THE NEEDLE HUB ON THE SYRINGE STARTED TO LEAK AND THEN BROKE OFF DURING THE INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326653 SOLESTA INJECTABLE GEL AGENT, BULKING, INJECTABLE FOR GASTR LNM PALETTE LIFE SCIENCES UNKNOWN

    Patients

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