BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAYPHA FILLER LIDOCAINE

    MDR report key: 24387283 · Received February 19, 2026

    Report

    Report Number
    3002806738-2026-00001
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 11, 2026
    Manufacturer
    CROMA-PHARMA GMBH
    Product Code
    LMH
    PMA / PMN Number
    P240008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    - FILLER WAS INJECTED AND IS NOT ACCESSIBLE FOR RETURN. - OFF-LABEL USE INTO CHEEK; DEVICE IS INDICATED TO CORRECT MODERATE TO SEVERE NASOLABIAL FOLDS AND FOR LIP AUGMENTATION. - NO HOSPITALIZATION OR SURGICAL INTERVENTION HAS BEEN REPORTED. PATIENT NOT RECOVERED TO DATE. SINCE UNKNOWN OUTCOME = F12. - FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE TO DATE OF THIS REPORT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT RECEIVED TREATMENT WITH SAYPHA FILLER LIDOCAINE IN THE CHEEK AREA IN (B)(6) 2024. FROM (B)(6) 2025 THE PATIENT UNDERWENT DENTAL TREATMENT WITH EXTRACTION OF 3 TEETH, ANTIBIOTICS ADMINISTERED CONTINUOUSLY, TREATMENT WAS COMPLETED IN NOVEMBER. FROM (B)(6) 2025 PATIENT NOTICED 2 LUMPS, ENT ORDERED MRI - GRANULOMAS WERE FOUND HERE, 5 DAYS ADMINISTRATION OF CLAVEMOS. ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL STATE THAT THE INITIAL TREATMENT WAS CONDUCTED IN (B)(6) 2024. BOTH SIDES WERE TREATED. GRANULOMAE PRESENT ON BOTH SIDES (19 AND 13 MM, RESPECTIVELY) ACCORDING TO MRI. TWELVE DAY PENICILLIN TREATMENT DID NOT SHOW ANY EFFECT. SURGICAL INTERVENTION MAY BE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311488 SAYPHA FILLER LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH CROMA-PHARMA GMBH 36957 905013

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other