BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA 4

    MDR report key: 17286425 · Received July 10, 2023

    Report

    Report Number
    3005975625-2023-00500
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 4, 2023
    Report Date
    July 10, 2023
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    UDI-DI
    07640173232704
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED 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 "SEQUELAE". 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 THIS RHA 4 PRODUCT.

    Description of Event or Problem · 0

    THIS CASE OCCURED OUTSIDE OF THE USA IN NORWAY. THE NORWEGIAN DISTRIBUTOR NOTIFIED TEOXANE OF AN ADVERSE EVENT ON (B)(6) 2023. A PATIENT WAS INJECTED ON (B)(6) 2023 IN CHIN WITH 0.1 ML OF TEOSYAL RHA 4 (THIS COMPLAINT) USING A CANNULA AND THE FANNING TECHNIQUE, AND WITH 0.3 ML OF TEOSYAL PURESENSE ULTRA DEEP ((B)(4)) USING THE NEEDLE PROVIDED IN THE BOX AND THE BOLUS TECHNIQUE. ONE DAY AFTER INJECTION, ON (B)(6) 2023, THE PATIENT EXPERIENCED A SEVERE VASCULAR OCCLUSION IN THE CHIN. AS CORRECTIVE ACTION, THE PATIENT WAS TREATED WITH HYALURONIDASE AS FOLLOWS: ON (B)(6) 2023: 2300 UNITS. ON (B)(6) 2023 : 1050 UNITS. ON (B)(6) 2023: 450 UNITS. AT THE TIME THE ADVERSE EVENT WAS REPORTED, WE WERE INFORMED THAT THE SYMPTOMS HAD COMPLETELY RESOLVED, CONFIRMED ON (B)(6) 2023. THE COMPLAINT WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147854 RHA 4 HYALURONIC ACID DERMAL FILLER LMH TEOXANE SA RHA® 4 US 1.2ml Schott/2 needles TSK 27G1/2 TPUL-22241IL0 07640173232704

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Other