BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 12851794 · Received November 22, 2021

    Report

    Report Number
    3005975625-2021-00649
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 22, 2021
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: ON OCT. 25, 2021 A LOCAL MEDICAL EXPERT WAS PUT IN CONTACT WITH THE INJECTOR TO ADVISE ON THIS CASE.

    Description of Event or Problem · 0

    THIS CASE OCCURRED OUTSIDE OF THE UNITED STATES, IN (B)(6). ACCORDING TO THE INFORMATION RECEIVED ON 28-OCT-2021, A FEMALE PATIENT WAS INJECTED ON (B)(6) 2021 WITH 0.15 ML TEOSYAL RHA 4 (TPUL-201025A0) INTO THE DORSUM NASI AND BRIDGE OF THE NOSE. APPROXIMATELY, 6 MONTHS POST-INJECTION, THE PATIENT PRESENTED WITH A GRANULOMATOUS REACTION AND A HARDENING AREA WITHOUT ANY SIGNS OF PHLOGOSIS ON THE RADIX AND BRIDGE AREAS OF THE NOSE. AS CORRECTIVE TREATMENTS, THE PATIENT RECEIVED : ON (B)(6) 2021: AN ANTI-INFLAMMATORY AGENT (GLUCOCORTICOID; METHYLPREDNISOLONE; URBASON 16 MG), ALONG WITH AN ANTIBIOTIC TREATMENT (DOXYCYCLINE) DURING 3 DAYS. ON (B)(6) 2021: 250 IU HYALURONIDASE INJECTION INTO THE RADIX AND BILATERAL SIDEWALL AREAS OF THE NOSE. ON (B)(6) 2021: 325 IU HYALURONIDASE INJECTION INTO THE CENTRAL AND RIGHT SIDE OF THE BRIDGE AREA OF THE NOSE. ON (B)(6) 2021, WE WERE INFORMED THAT FOLLOWING THE CORRECTIVE TREATMENT, THE EVENT WAS RESOLVING PROPERLY. ON (B)(6) 2021, WE WERE INFORMED THAT THE PATIENT RECEIVED ANOTHER DOSE OF HYALURONIDASE INJECTION (UNKNOWN IU). THE GRANULOMA WAS NO LONGER PALPABLE TO THE TOUCH, THE PATIENT WAS WELL, AND ONLY INFLAMMATION WAS PRESENT AT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749990 TEOSYAL RHA 4 DERMAL FILLER LMH TEOXANE SA NOT APPLICABLE TPUL-201025A0

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other