BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA 4

    MDR report key: 20246526 · Received September 18, 2024

    Report

    Report Number
    3005975625-2024-00511
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 18, 2024
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    UDI-DI
    07640173232704
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOFILMS THAT APPEAR WEEKS TO YEARS AFTER INJECTION ARE WELL-KNOWN AND DOCUMENTED ADVERSE REACTIONS TO HYALURONIC ACID FILLER INJECTIONS. THEY OCCUR WHEN INJECTED FILLER MATERIAL BECOMES CONTAMINATED WITH BACTERIA. THIS PROCESS GIVES RISE TO A PERMANENT LOW-GRADE CHRONIC INFECTION, AND IT MAY EVENTUALLY LEAD TO A CHRONIC GRANULOMATOUS REACTION. GIVEN THE STERILITY OF THE GEL, THEY ARE RATHER DUE TO A LACK OF ASEPSIS DURING INJECTION AND/OR POSTTREATMENT CARE. IT CAN ALSO OCCUR BY REACTIVATING A PREVIOUSLY QUIESCENT BIOFILM THAT FORMED AFTER A PREVIOUS FILLER TREATMENT OR AFTER A BACTEREMIA. APPROPRIATE TREATMENT ALLOWS PROGRESSIVE RESOLUTION OF THE SYMPTOMS. THE RISK OF SUCH REACTIONS IS MENTIONED IN THE INSTRUCTIONS FOR USE OF THIS RHA 4.

    Description of Event or Problem · 0

    THIS CASE OCCURRED OUTSIDE OF THE USA, IN SPAIN. THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 15-AUG-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH THE FOLLOWING PRODUCTS: 1 ML OF TEOSYAL PURESENSE ULTRA DEEP IN THE MIDDLE THIRD AND CHEEKBONES, (RC/2408032). 1.2 ML OF RHA 4 IN THE NASOLABIAL FOLDS, LABIOMENTALIS GROOVE, AND IN THE CHEEKS (CURRENT COMPLAINT). OTHER PRODUCTS (RHA3, AND TEOSYAL PURESENSE REDENSITY 2) WERE INJECTED ON THE SAME DAY BUT NO ADVERSE EVENTS WERE REPORTED AT THESE INJECTION SITES. THE PATIENT ALSO HAD A HISTORY OF TEOXANE INJECTIONS WITH THE SAME PRODUCTS IN 2023 IN THE MIDDLE THIRD, NALOLABIALFOLDS, AND MAROINETTE LINES WITHOUT ANY ISSUE. APPROXIMATIVELY 3 MONTHS AFTER THE INJECTION, ON (B)(6) 2024 (THE DATE NEEDS TO BE CONFIRMED BECAUSE OF CONTRADICTORY INFORMATION), THE PATIENT NOTICED MILD FACIAL INFLAMMATION ACCOMPANIED BY INDURATION ON CHEEKBONES, ESPECIALLY ON THE RIGHT SIDE. THE PATIENT NOTICED IT WHILE BEING ON THE BEACH AND WHILE DOING SPORTS, AND THE SYMPTOM WAS CONFIRMED ON (B)(6) 2024 DURING A CONSULTATION. THE PATIENT WAS PRESCRIBED A TAPERING DOSE OF CORTICOSTEROID (PREDNISONE 30 MG) FOR 12 DAYS, AN ANTIBIOTIC (CIPROFLAXINE 500 MG) FOR 7 DAYS, AND ONE VIAL OF HYALURONIDASE. 9 DAYS LATER, ON (B)(6) 2024, THE PATIENT COMPLAINED ABOUT A MODERATE INFLAMMATION IN THE NASOLABIAL FOLDS ON BOTH SIDES. SHE WAS PRESCRIBED A FOOD SUPPLEMENT (DRAINAQUA) AND A WOUND TREATMENT (VARIDASE). THE MEDICAL HISTORY OF THE PATIENT MENTIONED A HISTORY OF HERPES AND A DENTAL SURGERY REPORTED AS BEING ON (B)(6) 2024. ON (B)(6) 2024, A BLOOD TEST (BLOOD COUNT) WAS PERFORMED WITHOUT LEUKOCYTOSIS. IN ADDITION, THE PATIENT HAD NO FEVER OR SYMPTOMS, AS WELL AS NO REDNESS OR HEAT IN THE AREA. ON (B)(6) 2024, WE WERE INFORMED THAT THE LOCAL MEDICAL EXPERT WAS CONTACTED, AND ACCORDING TO HIM, THE SYMPTOMS DESCRIBED COULD BE LINKED TO A BIOFILM. THEREFORE, HE ADVISED TO EXTEND THE ANTIBIOTIC REGIMEN TO 2 WEEKS AND TO INJECT HYALURONIDASE. ACCORDING TO THIS NEW DIAGNOSIS, THE CASE WAS UPGRADED TOO REPORTABLE. ON (B)(6) 2024 (DATE OF THE INITIAL EMAIL) THE SYMPTOMS WERE RESOLVING; THE SYMPTOMS WERE RESOLVING. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION IS AVAILABLE, BUT THE SITUATION AND SYMPTOMS REMAIN MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318684 RHA 4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA 23161IL0 07640173232704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other