BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 7348000 · Received March 19, 2018

    Report

    Report Number
    3005975625-2018-00001
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    February 16, 2018
    Report Date
    March 15, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 OR CLOSE TO A BLOOD VESSEL LEADING TO AN OCCLUSION OR A COMPRESSION 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. MANAFI A, BARIKBIN B, MANAFI A, HAMEDI ZS, MOGHADAM SA. NASAL ALAR NECROSIS FOLLOWING HYALURONIC ACID INJECTION INTO NASOLABIAL FOLDS: A CASE REPORT. WORLD JOURNAL OF PLASTIC SURGERY. 2015;4(1).

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). THE INITIAL REPORTER INFORMED TEOXANE (B)(4) ON 02/18/2018 THAT AN EVENT OCCURRED IN A PATIENT, AFTER BEING INJECTED WITH 0.7 ML OF THE PRODUCT TEOSYAL RHA 2 INTO THE UPPER LIP. THE PATIENT PRESENTED WITH EARLY VASCULAR OCCLUSION. ON 02/22/2018, COMPLEMENTARY INFORMATION WAS PROVIDED TO TEOXANE (B)(4) BY THE INITIAL REPORTER: THE PATIENT WAS INJECTED ON (B)(6) 2018 AND THE REACTION OCCURRED ON (B)(6) 2018. THE PATIENT WAS TREATED BY HYALURONIDASE INJECTIONS AND PRESCRIPTIONS OF ANTIBIOTICS. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS RECOVERING WELL, IMPROVEMENTS WERE SEEN DAILY. THE HEALING WITHOUT INCIDENT WAS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER REGARDING THE PATIENT'S RECOVERY AFTER THE 02/22/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191911 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP30L-171117C

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other