BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 8815552 · Received July 23, 2019

    Report

    Report Number
    3005975625-2019-00018
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 22, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT OBSERVED IS LIKELY TO BE LINKED TO A VASCULAR COMPLICATION. 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). 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 ADVERSE EVENT HAPPENED OUTSIDE OF THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, 13 DAYS AFTER THE INJECTIONS OF TEOSYAL RHA 3 IN THE LIPS AREA, THE PATIENT PRESENTED WITH EARLY ONSET NECROSIS OF THE INJECTION AREA. THE INTENSITY IS REPORTED MODERATE. THIS EVENT IS DESCRIBED AS BLISTERS (YELLOW COLOR). PATIENT WAS ADMITTED TO A CLINIC IN ORDER TO TREAT THE REACTION. ACCORDING TO THE RECEIVED INFORMATION, HYALASE 1500UI WAS APPLIED, AS WELL AS ASPIRIN AND CLARITHROMYCIN ON (B)(6) 2019. ON (B)(6) 2019, THE ADVERSE EVENT IS REPORTED AS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612647 TEOSYAL RHA 3 HYALOURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP27L-184111C

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other