BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA 4

    MDR report key: 18228693 · Received November 29, 2023

    Report

    Report Number
    3005975625-2023-00812
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    January 2, 2023
    Report Date
    November 29, 2023
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VASCULAR COMPLICATIONS ARE RARE AND SERIOUS SIDE EFFECTS, ALTHOUGH THEY ARE WIDELY KNOWN AND DOCUMENTED IN THE CONTEXT OF DERMAL FILLER INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE A BLOOD VESSEL, LEADING TO ITS OCCLUSION. THE LOCAL DEPRIVATION OF BLOOD SUPPLY CAUSES TISSUE ANOXIA. IF ENOUGH HYALURONIDASE IS INJECTED ON TIME, SYMPTOMS CAN BE FULLY RESOLVED WITHOUT SEQUALAE. IF THE VASCULAR COMPLICATION IS NOT DETECTED, DIAGNOSED, AND TREATED PROMPTLY, IT CAN LEAD TO SKIN NECROSIS. THE RISK OF SUCH ADVERSE REACTIONS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF TEOSYAL PRODUCTS.

    Description of Event or Problem · 0

    THIS CASE OCCURED OUTSIDE OF THE USA, IN FRANCE. A DOCTOR NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 02-NOV-2023. THE PATIENT WAS INJECTED WITH 0.3 ML OF TEOSYAL RHA 4 ON 30-DEC-2023 IN THE NASOLABIAL FOLDS. AND THREE DAYS AFTER, THE PATIENT PRESENTED WITH A VASCULAR SKIN DISORDER IN THE NOSE TIP OF LOW INTENSITY WITH SOME LIGHT CRUSTING. THE INJECTOR PROVIDED THE FOLLOWING MEDICAL TREATMENTS TO THE PATIENT ON 02-JAN-2023: - HYALURONIDASE 1000 UI PER DAY FOR 4 DAYS, - LOW MOLECULAR WEIGHT HEPARIN (LMWH) 40 MG, IS AN ANTICOAGULANT FOR 5 DAYS, - ACIDE ACÉTYLSALICYLIQUE (ASA) 75 MG, IS AN ANTI-INFLAMMATORY FOR 5 DAYS, - AMOXYCILLIN / CLAVULANIC ACID 1G X3 PER DAY, IS AN ANTIBIOTIC FOR 10 DAYS. AFTER 4 WEEKS, THE PATIENT COMPLETELY RECOVERED. THUS, THIS COMPLAINT WAS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59069 RHA 4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other