BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 9295533 · Received November 8, 2019

    Report

    Report Number
    3005975625-2019-00025
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    August 29, 2019
    Report Date
    November 8, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH RECORDS FOR THE CONCERNED BATCH NUMBER WAS PERFORMED. THEY APPEARED TO BE WITHIN SPECIFICATIONS, MEANING NO DEFAULTS HAD BEEN HIGHLIGHTED DURING PRODUCTION. NO OTHER INCIDENTS HAVE BEEN REPORTED WITH THIS BATCH NUMBER. 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 INCIDENT OCCURED OUTSIDE THE UNITED STATES, IN (B)(6). THE INFORMATION AND PICTURES RECEIVED ARE MATCHING WITH A VASCULAR COMPROMISE WHICH TURNED INTO A NECROSIS FOLLOWING THE INJECTION OF TEOSYAL RHA 3 IN THE GLABELLA ON (B)(6) 2019. THE PICTURES RECEIVED ON 2019-10-01 CONFIRMED THAT THE EVOLUTION OF THE SYMPTOMS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091145 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP27L-190321A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other