BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 8815553 · Received July 23, 2019

    Report

    Report Number
    3005975625-2019-00020
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 28, 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
    SZ
    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

    THIS ADVERSE EVENT HAPPENED OUTSIDE OF THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, ON THE DAY OF THE INJECTIONS OF TEOSYAL RHA2 IN THE LIPS AREA, THE PATIENT PRESENTED WITH AN IMMEDIATE BLANCHING OF THE TREATED AREA IMMEDIATELY AFTER THE INJECTION IN THE LOWER LEFT LIP. THE CAPILLARY REFILL TIME (CRT) WAS REPORTED TO BE 4 SECONDS. 3 HOURS LATER, THE BLANCHING EXTENDED TO THE CHIN AREA AND BECAME PAINFUL FOR THE PATIENT, CRT WAS 2,5 SECS. SEVERAL LIDOCAINE SESSIONS WERE INITIATED WITH MASSAGE LEADING TO AN IMPROVEMENT IN THE COLOUR OF THE REACTION AREA, WHICH WAS REPORTED PINK AND WITH A CRT OF 1 SECOND 4 HOURS LATER. ON (B)(6) 2019, PAIN WAS DECREASING, AREA WAS STILL ITCHY, SWOLLEN AND PRESENTED SOME BRUISES. ON (B)(6) 2019, THE EVOLUTION WAS GOOD, PAIN WAS STILL PRESENT, THE CIRCULATION WAS RESTORED AND THE COLOR OF THE AREA WAS GOOD. THERE REMAINED A HEMATOMA AND A SORE ON THE LIP. ON (B)(6) 2019, A NEW BRUISE APPEARED ON THE UPPER LIP. ON (B)(6) 2019, THE RESOLUTION OF THE SYMPTOMS WAS COMPLETE. ACCORDING TO THE RECEIVED INFORMATION, HYALASE (1500IU+1CC SALINE) WAS INJECTED IN THE REACTION SITE, 5 TIMES IN TOTAL SINCE THE START OF THE REACTION, AND OVER A COURSE OF 4 HOURS. ADDITIONALLY, XYLOCAINE WITH ADRENALINE WAS ALSO INJECTED IN THE REACTION SITE IN ORDER TO REDUCE PAIN AT THE REACTION SITE. PATIENT'S GP WAS ALSO CONSULTED AND PRESCRIBED ANTIBIOTICS OVER THE NEXT FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612648 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP30L-182415B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other