BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA REDENISTY

    MDR report key: 21983935 · Received May 8, 2025

    Report

    Report Number
    3005975625-2025-00035
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    UDI-DI
    7640173231653
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VASCULAR COMPLICATIONS ARE RARE AND SERIOUS SIDE EFFECTS, ALTHOUGH THEY ARE WIDELY KNOWN AND DOCUMENTED IN THE CONTEXT OF DERMAL FILLER INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE A BLOOD VESSEL, LEADING TO ITS OCCLUSION, OR TO A HIGH AMOUNT OF PRODUCT INJECTED NEAR A VESSEL, LEADING TO ITS COMPRESSION. THE LOCAL DEPRIVATION OF BLOOD SUPPLY CAUSES TISSUE ANOXIA. IF ENOUGH HYALURONIDASE IS INJECTED ON TIME, SYMPTOMS CAN BE FULLY RESOLVED WITHOUT SEQUALAE. IF THE VASCULAR COMPLICATION IS NOT DETECTED, DIAGNOSED, AND TREATED PROMPTLY, IT CAN LEAD TO SKIN NECROSIS. THE RISK OF SUCH ADVERSE REACTIONS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF PRODUCTS. MOREOVER, LOCAL REACTIONS THAT MAY MANIFEST AS EARLY SWELLING AND BRUISES AFTER INJECTION ARE WELL-KNOWN AND DOCUMENTED ADVERSE REACTIONS TO HYALURONIC ACID FILLER INJECTIONS. THESE REACTIONS ARE RELATED TO THE TRAUMATIC ENVIRONMENT OF THE INJECTION, VARY ACCORDING TO INJECTION VOLUME AND TECHNIQUE AND PATIENT FACTORS, AND ARE USUALLY RESOLVED SPONTANEOUSLY. MOREOVER, THE RISK OF SUCH REACTIONS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF PRODUCTS. OF NOTE, RHA 4 IS NOT INDICATED FOR CHIN, JAWLINE, AND TEMPLES IN THE US.

    Description of Event or Problem · 0

    PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 11-APR-2025. A FEMALE PATIENT HAD BEEN INJECTED ON (B)(6) 2025 WITH 13 SYRINGES IN TOTAL OF THE FOLLOWING PRODUCTS: 6 ML OF RHA 4 IN THE CHIN (1 ML), JAWLINE (1 ML), CHEEKS (1 ML), AND TEMPLES (3 ML) USING THE FANNING TECHNIQUE, NEEDLE PROVIDED IN THE BOX, AND 27G CANNULA (RC/2504047). 4 ML OF RHA REDENSITY IN THE ORAL COMMISSURES (0.5 ML), LIP OUTLINE (0.5 ML), PERIORAL AREA (1 ML), AND TEMPLES (2 ML), USING THE NEEDLE PROVIDED IN THE BOX, AND 27G CANNULA (CURRENT COMPLAINT). 1 ML OF RHA 3 IN THE LIPS (1 ML) USING THE NEEDLE PROVIDED IN THE BOX, AND 27G CANNULA (RC/2504049). 2 ML OF RHA 2 IN THE RADIAL CHEEK LINES AREA (1 ML), AND NASOLABIAL FOLDS (1 ML) USING THE NEEDLE PROVIDED IN THE BOX, AND 27G CANNULA (NON-REPORTABLE RC/2504050). 100 UNITS OF BOTULINUM TOXIN (DAXXIFY) IN THE CROW'S FEET AND PLATYSMAL BANDS. ON THE SAME DAY AFTER THE INJECTION, ON (B)(6) 2025, THE PATIENT WAS SWOLLEN AND BRUISED FROM MULTIPLE POKES. THREE DAYS LATER, ON (B)(6) 2025, THE PATIENT EXPERIENCED MODERATE TENDERNESS/SUDDEN PAIN (5/10) WHICH BECAME MORE PAINFUL AND SORE AS TIME WENT ON, DISCOLORATION, AND WHITE PUSTULES IN THE CHIN, MENTALIS, AND LIP AREA. AS TREATMENT, THE INJECTOR PRESCRIBED ANTIBIOTIC OINTMENT FOR A FEW DAYS, AS THE SKIN MIGHT HAVE BEEN IRRITATED. THE PATIENT WAS SEEN BY OTHER DOCTORS, WHO GAVE OTHER (UNKNOWN) OPINIONS. FOLLOWING THIS, THE PATIENT WENT TO ANOTHER INJECTOR WHO PERFORMED AN ULTRASOUND EXAMINATION AND CONFIRMED VASCULAR OCCLUSION IN THE CHIN, LIP, AND PERIORAL AREA. SINCE RHA 3, RHA 4, AND RHA REDENSITY COULD NOT BE EXCLUDED AS SUSPECTS (ALL WERE INJECTED ON THE SAME DAY, CLOSED TO THE VASCULAR COMPLICATION AREA), CASES WERE ASSESSED AS REPORTABLE. THE PATIENT WAS TREATED WITH 525 UI OF HYALURONIDASE (HYLENEX) IN THE MENTALIS AREA, AS THE INSIDE OF THE MOUTH WAS ALSO DISCOLORED UPON ASSESSMENT. ADDITIONALLY, THE PATIENT RECEIVED PRESCRIPTIONS FROM THE PHARMACY, WAS ADVISED TO UNDERGO RED LIGHT THERAPY, USE WARM COMPRESSES, AND MASSAGE THE AFFECTED AREAS. IN THE FOLLOWING DAYS, THE PATIENT RETURNED TO THE TREATING INJECTOR, AND THE AFFECTED AREAS WERE RESOLVING, THUS THE CASE WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035842 RHA REDENISTY HYALURONIC ACID DERMAL FILLER LMH TEOXANE SA SEE B6 7640173231653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other