BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 7226997 · Received January 30, 2018

    Report

    Report Number
    3005975625-2017-00002
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    November 28, 2017
    Report Date
    December 21, 2017
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN NECROSIS ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS AS PART OF HYALURONICA 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).

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). THE INITIAL REPORTER (TREATING PHYSICIAN) INDICATES THAT FOUR DAYS AFTER THE INJECTION (BY ANOTHER PRACTITIONER) OF THE PRODUCT IN THE GLABELLA AREA (INJECTION VOLUME OF 0.2 ML), THE PATIENT PRESENTED WITH MODERATE NECROSIS OF THE GLABELLA AND SURROUNDING AREA. THE INITIAL REPORTER STATES TO HAVE SUCCESSFULLY TREATED THE ADVERSE EVENT WITH THE FOLLOWING MEDICATIONS: - HYALURONIDASE INJECTION OVER 2 DAYS, STARTING ON (B)(6) 2017, - ASPIRIN, - OXYGEN CHAMBER. ACCORDING TO THE INITIAL REPORTER, THE ADVERSE REACTION IS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71583 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP30L-171414A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other