BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 8460619 · Received March 28, 2019

    Report

    Report Number
    3005975625-2019-00008
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 28, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VASCULAR COMPLICATIONS (OCCLUSIONS) ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS AS PART OF HYALURONIC ACID-BASED DERMAL FILLERS INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE A BLOOD VESSEL LEADING TO AN OCCLUSION AND BLOCKING THE BLOOD FLOW, GENERALLY REFERED TO AS VASCULAR COMPLICATION. IF THE VASCULAR COMPLICATION IS NOT DETECTED/DIAGNOSED AND TREATED TIMELY, IT CAN LEAD TO A SKIN NECROSIS. THE RISK OF VASCULAR COMPLICATION AND SKIN NECROSIS ARE MENTIONED IN THE PRODUCT LABELLING. LITERATURE DATA: DELORENZI C. "COMPLICATIONS OF INJECTABLE FILLERS, PART 2: VASCULAR COMPLICATIONS." AESTHET SURG J. 2014; 34 (4): 584-600. FUNT D, PAVICIC T. "DERMAL FILLERS IN AESTHETICS: AN OVERVIEW OF ADVERSE EVENTS AND TREATMENT APPROACHES." CLIN COSMET INVESTIG DERMATOL 2013; 6: 295-316.

    Description of Event or Problem · 1

    THE DESCRIBED EVENT HAPPENED OUTSIDE THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT PRESENTED WITH A VASCULAR OCCLUSION ON THE SUPRAORBITAL ARTERY FOLLOWING THE INJECTION OF TEOSYAL RHA 2 IN THE FOREHEAD ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254010 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP30L-182011A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other