BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 8270331 · Received January 23, 2019

    Report

    Report Number
    3005975625-2019-00001
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 27, 2018
    Report Date
    January 23, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 COMPLICATION FOLLOWING THE INJECTION OF 0.9 ML OF TEOSYAL RHA 3 IN THE LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64125 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP27L-180911A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other