BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 8522995 · Received April 17, 2019

    Report

    Report Number
    3005975625-2019-00011
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    November 23, 2018
    Report Date
    April 17, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFORMATION AND THE PHOTOS, THE CASE IS LIKELY TO BE A VASCULAR COMPROMISE. 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. BIBLIOGRAPHY: 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

    THIS EVENT HAPPENED OUTSIDE OF THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, TWO DAYS AFTER THE INJECTIONS, THE PATIENT EXPERIENCED A DARK BLUE AREA IN THE LEFT TEMPLE, WITH RED DISCOLORATIONS IN THE HAIRLINE, WHICH HAS BEEN CONSIDERED AS A VASCULAR COMPROMISE. AN EXPERT WAS CONSULTED BY THE INJECTOR AND A TREATMENT WITH HYALASE 3000 IU WAS INITIATED ON THE DAY OF THE REACTION, WITH ONE SESSION IN THE MORNING AND A SECOND ONE IN THE EVENING. THIS INDUCED A REVASCULARIZATION OF THE AREA AND A THIRD HYALURONIDASE SESSION WAS DEEMED NOT NECESSARY BY THE INJECTOR AND THE PATIENT. ON (B)(6) 2019, THE RESOLUTION HAS BEEN REPORTED AS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317526 TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TPUL-180324A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other