BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 7226998 · Received January 30, 2018

    Report

    Report Number
    3005975625-2017-00003
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    November 27, 2017
    Report Date
    January 5, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN NECROSIS 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).

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). THE INITIAL REPORTER INFORMED TEOXANE S.A. ON 12/05/2017 THAT AN EVENT OCCURRED WITHOUT ANY FURTHER DETAILS. ON 12/11/2017 COMPLEMENTARY INFORMATION WAS RECEIVED, INCLUDING PICTURES SHOWING A SERIOUS ADVERSE REACTION, THAT OCCURRED THE DAY THE INJECTION TOOK PLACE, AFTER INJECTION OF THE PRODUCT INTO THE UPPER LIP. THE PRACTITIONER REPORTS THE OCCURRENCE OF SEVERE EDEMA AND PAIN, HOWEVER IN OUR OPINION THE DESCRIPTION MORE LIKELY MATCHED WITH A SKIN NECROSIS FOLLOWING A VASCULAR COMPLICATION. CONSIDERING THE PROVIDED INFORMATION, THE APPEARANCE OF THE REACTION, AND THE INITIAL REPORTER'S DIAGNOSIS, A THIRD OPINION WAS DEMANDED TO A MEDICAL EXPERT. THE MEDICAL EXPERT'S ADVICE CONCURRED WITH THE CONCLUSION THAT THE INCIDENT WAS RELATED TO A SKIN NECROSIS (CAUSED BY AN ACCIDENTAL INJECTION OF THE PRODUCT INSIDE OR CLOSE TO A BLOOD VESSEL). HOWEVER THE INITIAL REPORTER DID NOT AGREE WITH THIS ADVICE, STATING THAT IT WAS A VENOUS STASIS (WHICH IS A VASCULAR COMPLICATION), AND THAT THE SITUATION STARTED TO IMPROVE UNDER STEROIDS AND ANTIBIOTICS TREATMENT (INFORMATION DATED (B)(6) 2017). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER REGARDING THE PATIENT'S RECOVERY AFTER THE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71584 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP27L-164911A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other