BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA4

    MDR report key: 16458868 · Received March 1, 2023

    Report

    Report Number
    3005975625-2023-00077
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    December 29, 2022
    Report Date
    March 1, 2023
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SKIN INFECTIONS ARE WELL KNOWN AND DESCRIBED ADVERSE REACTIONS FOLLOWING DERMAL FILLER INJECTIONS. THEY CAN HAPPEN AFTER AN INJECTION WITH AN IMPROPER TECHNIQUE, INDUCING A LACK OF ASEPSIS OF THE INJECTION ENVIRONMENT, WHICH IN SOME CASE MAY RESULT IN SEPSIS. EXTERNAL FACTORS, SUCH AS THE USE OF MAKEUP IMMEDIATELY AFTER THE INJECTION, CAN ALSO INCREASE THE RISK OF SKIN INFECTION. ADEQUATE TREATMENT WITH ANTIBIOTICS LEADS TO A COMPLETE RESOLUTION OF THE SYMPTOMS WITHOUT SEQUELAE. ADDITIONALLY, THE RISK OF SUCH ADVERSE EVENTS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF TEOSYAL PRODUCTS.

    Description of Event or Problem · 0

    THIS CASE OCCURED OUTSIDE OF THE USA, IN SPAIN. ACCORDING TO THE INFORMATION RECEIVED ON 31-JAN-2023, A PATIENT WAS INJECTED ON (B)(6) 2022 WITH 1.2 ML OF TEOSYAL RHA 4 (22162FL0) IN THE CHEEKS (0.6 ML TO EACH CHEEK). ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN INFECTION OF MODERATE INTENSITY, WITH INFLAMMATION AND A LOT OF PAIN WITH OUT PALPATION IN THE RIGHT CHEEKBONE. AS CORRECTIVE ACTION ON (B)(6) 2022, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS TREATED WITH ANTIBIOTIC (CEFUROXIME 500 MG, FOR 5 DAYS) AND WITH AN INJECTION OF CORTICOSTEROID. ON (B)(6) 2023, THE PATIENT'S CONDITION WORSENED AND SHE WENT TO SEE HER FAMILY DOCTOR WHO PRESCRIBED CORTICOSTEROID (ZAMENE 30MG) AND EXTENDED THE ANTIBIOTIC BY REPLACING IT WITH ANOTHER ANTIBIOTIC (AUGMENTIN 875/125 MG). ON (B)(6) 2023, THE PATIENT COULD NOT SEE ANY IMPROVEMENT THEREFORE SHE CONSULTED ANOTHER DOCTOR AND REQUESTED TO HAVE THE GEL REMOVED. THE PATIENT REPORTED THAT HER DOCTOR TOLD HER SHE WAS AT RISK OF LOSING BONE TISSUE BECAUSE OF THE INFECTION. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH HYALURONIDASE (190 UI IN TOTAL) AND CONTINUED THE ANTIBIOTIC TREATMENT (AUGMENTIN 875/125 MG). A MEDICAL ASSISTANCE WAS PROVIDED ON (B)(6) 2023. THE INJECTOR INFORMED THE MEDICAL EXPERT THAT THE PATIENT DID NOT FOLLOW ANY TREATMENT AND THAT IT WAS AN UNCONTROLLED CASE. THE LOCAL MEDICAL EXPERT EXPLAINED THAT UNTIL THE INFECTION IS NOT CONTROLLED, HYALURONIDASE SHOULD NOT BE APPLIED. THE PATIENT SITUATION, AND SYMPTOMS' EVOLUTION ARE BEING MONITORED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054487 TEOSYAL RHA4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA TPUL-22162FL0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other