BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 9664015 · Received February 4, 2020

    Report

    Report Number
    3005975625-2020-00005
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    October 20, 2019
    Report Date
    February 4, 2020
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLEASE REFER TO THE LITERATURE DATA BELOW. 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). HONG, J.Y., ET AL., IMPENDING SKIN NECROSIS AFTER DERMAL FILLER INJECTION: A "GOLDEN TIME" FOR FIRST-AID INTERVENTION. DERMATOL THER, 2017. 30(2). MARUYAMA, S., A HISTOPATHOLOGIC DIAGNOSIS OF VASCULAR OCCLUSION AFTER INJECTION OF HYALURONIC ACID FILLER: FINDINGS OF INTRAVASCULAR FOREIGN BODY AND SKIN NECROSIS. AESTHET SURG J, 2017. 37(9): P. NP102-NP108. SALVAL, A., ET AL., IMPENDING FACIAL SKIN NECROSIS AND OCULAR INVOLVEMENT AFTER DERMAL FILLER INJECTION: A CASE REPORT. AESTHETIC PLAST SURG, 2017. 41(5): P. 1198-1201. WANG, Q., ET AL., VASCULAR COMPLICATIONS AFTER CHIN AUGMENTATION USING HYALURONIC ACID. AESTHETIC PLAST SURG, 2018. 42(2): P. 553-559.

    Description of Event or Problem · 1

    THE PRESENT EVENT HAPPENED OUTSIDE OF THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, AFTER BEING INJECTED IN THE LIPS A FEW DAYS AGO, THE PATIENT PRESENTED WITH A SEVERE ADVERSE REACTION, LIKELY TO BA A VASCULAR COMPROMISE IN THE UPPER LIP AREA. ACCORDING TO THE RECEIVED INFORMATION, THE INJECTOR MONITORED THE SITUATION OVER THE WEEKEND, AND SAW HER ON (B)(6) 2019. DURING THIS VISIT, THE INJECTOR CONSTATED THAT THE SYMPTOMS WERE IN LINE WITH A VASCULAR OCCLUSION, AND DID A PATCH TEST AND INJECTED HYALASE 1500 IU IN SEVERAL SITES OF THE AREA, ESPECIALLY UNDER THE VESSEL THAT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129744 TEOSYAL RHA 3 HYALURONIC ACID DERML FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP27L-191321B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other