BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA 3

    MDR report key: 16860237 · Received May 3, 2023

    Report

    Report Number
    3005975625-2023-00271
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 3, 2023
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION AND PICTURES RECEIVED POINT TO A VASCULAR OCCLUSION. VASCULAR COMPLICATIONS ARE RARE SERIOUS SIDE EFFECTS, ALTHOUGH WIDELY KNOWN AND DOCUMENTED IN THE CONTEXT OF FILLER INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE OR CLOSE TO A BLOOD VESSEL, LEADING TO ITS OCCLUSION OR COMPRESSION, BLOCKING THE BLOOD FLOW. IF TREATED ON TIME WITH AN APPROPRIATE TREATMENT, SYMPTOMS CAN BE FULLY RESOLVED WITHOUT SEQUALAE. IF THE VASCULAR COMPLICATION IS NOT DETECTED/DIAGNOSED AND TREATED TIMELY, IT CAN LEAD TO A SKIN NECROSIS. THE RISK OF SUCH ADVERSE REACTIONS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF TEOSYAL PRODUCTS.

    Description of Event or Problem · 0

    PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 30 MARCH 2023. A PATIENT WAS INJECTED ON (B)(6) 2023 WITH APPROXIMATELY 1.5 ML OF TEOSYAL RHA3 IN THE LIPS (0.325ML EACH SIDE ON THE TOP AND 0.4ML IN THE BOTTOM). THE INJECTION WAS DONE USING THE NEEDLE PROVIDED IN THE BOX. THE SAME DAY OF INJECTION, THE PATIENT EXPERIENCED BLANCHING, BRUISING, DROOPING, SWELLING, DISCOLOURATION AND CRUSTING ON LIPS. WE WERE INFORMED THAT THE PATIENT HAS HISTORY OF FILLER INJECTION IN THE LIP IN 2022 WITH RESTIYANE DEFINE & KISS. THE INJECTOR TREATED THE PATENT WITH SEVERAL INJECTIONS OF HYALURONIDASE (HYLENEX) AS FOLLOWS: ON (B)(6) 2023: 12 IU. ON (B)(6) 2023: 300 I.U. ON (B)(6) 2023: 75 I.U. ON (B)(6) 2023: 90 I.U. ON (B)(6) 2023 EVENING, THE PATIENT ALSO PRESENTED TO THE ER FOR PAIN AND RECEIVED A SHOT OF NON-STEROID ANT-INFLAMMATORY (TORADOL). ON (B)(6) 2023, THE PATIENT VISITED THE INJECTOR WHO PERFORMED DENTAL BLOCK EACH TIME TO DECREASE THE PAIN THE PATIENT WAS COMPLAINING ABOUT. ON (B)(6) 2023, THE SITUATION IMPROVED AS ONLY SLIGHT REDNESS AS WELL AS TENDERNESS ON THE CHEEK WERE OBSERVED. BASED ON THE FIRST INFORMATION RECEIVED, THE CASE WAS ASSESSED NOT REPORTABLE. HOWEVER, ACCORDING TO THE PICTURE RECEIVED ON (B)(6) 2023, THE CASE WAS UPGRADED AS REPORTABLE DUE TO EVIDENCE OF VASCULAR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714140 RHA 3 HYALURONIC ACID DERMAL FILLER LMH TEOXANE SA TP27L-22181A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other