BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA INJECTABLE GEL

    MDR report key: 22819797 · Received August 15, 2025

    Report

    Report Number
    3014909464-2025-00033
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "I AM PLANNING TO REMOVE SOLESTA ON (B)(6) 2025." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, INDICATED THAT "THE PATIENT IS EXPERIENCING PAIN. [PHYSICIAN] REPORTS A PATIENT WHO HAS RECEIVED 2 ROUNDS OF SOLESTA IN THE LAST SIX YEARS WITH A THIRD ROUND OF INJECTION 7 TO 8 MONTHS AGO. THE PATIENT IS NOW COMPLAINING OF PALPABLE BLEB IN THE VAGINA WITH DISCOMFORT DURING INTERCOURSE. PATIENT STATES THE BLEB CAN BE FELT AT ALL TIMES, EVEN WITH NO ACTIVITY. [PHYSICIAN] PLANS TO REMOVE SOLESTA ON (B)(6), 2025, AND REQUESTS THAT A [PALETTE LIFE SCIENCES REPRESENTATIVE] BE PRESENT. [PHYSICIAN] ALSO REQUESTED ADDITIONAL TRAINING ON SOLESTA." FURTHER ADDITIONAL INFORMATION RECEIVED ON JULY 28, 2025, STATES THAT "[PALETTE LIFE SCIENCES REPRESENTATIVE] SPOKE WITH THE [PHYSICIAN] REGARDING THIS PATIENT AND THE PLAN WILL BE TO EXPLANT THE ONE BLEB OF SOLESTA THAT IS PALPABLE WITHIN THE VAGINA. [PALETTE LIFE SCIENCES REPRESENTATIVE] WILL BE ATTENDING THE CASE AS PER THE [PHYSICIAN]'S REQUEST. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "I AM PLANNING TO REMOVE SOLESTA ON (B)(6) 2025." ADDITIONAL INFORMATION RECEIVED ON JULY 23, 2025, INDICATED THAT "THE PATIENT IS EXPERIENCING PAIN. [PHYSICIAN] REPORTS A PATIENT WHO HAS RECEIVED 2 ROUNDS OF SOLESTA IN THE LAST SIX YEARS WITH A THIRD ROUND OF INJECTION 7 TO 8 MONTHS AGO. THE PATIENT IS NOW COMPLAINING OF PALPABLE BLEB IN THE VAGINA WITH DISCOMFORT DURING INTERCOURSE. PATIENT STATES THE BLEB CAN BE FELT AT ALL TIMES, EVEN WITH NO ACTIVITY. [PHYSICIAN] PLANS TO REMOVE SOLESTA ON (B)(6) 2025, AND REQUESTS THAT A [PALETTE LIFE SCIENCES REPRESENTATIVE] BE PRESENT. [(B)(6)] ALSO REQUESTED ADDITIONAL TRAINING ON SOLESTA." FURTHER ADDITIONAL INFORMATION RECEIVED ON JULY 28, 2025, STATES THAT "[PALETTE LIFE SCIENCES REPRESENTATIVE] SPOKE WITH THE [(B)(6)] REGARDING THIS PATIENT AND THE PLAN WILL BE TO EXPLANT THE ONE BLEB OF SOLESTA THAT IS PALPABLE WITHIN THE VAGINA. [PALETTE LIFE SCIENCES REPRESENTATIVE] WILL BE ATTENDING THE CASE AS PER THE [(B)(6)]'S REQUEST. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788624 SOLESTA INJECTABLE GEL AGENT, BULKING, INJECTABLE LNM PALETTE LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female NONE REPORTED.