BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 16012353 · Received December 20, 2022

    Report

    Report Number
    3005975625-2022-00741
    Event Type
    Injury
    Date Received
    December 20, 2022
    Report Date
    December 20, 2022
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MFR NARRATIVE: ACCORDING TO THE INFORMATION RECEIVED THIS CASE WOULD BE RELATED TO THE INFLAMMATORY RECTION OF THE BODY IN RESPONSE TO THE IMPLANT, WHICH ARE KNOWN AND WIDELY DOCUMENTED EFFECTS IN THE CONTEXT OF HYALURONIC ACID FILLER INJECTIONS. GRANULOMAS ARE KNOWN AND WIDELY DOCUMENTED EFFECTS IN THE CONTEXT OF HYALURONIC ACID FILLER INJECTIONS. THEY ARE CAUSED BY A DELAYED IMMUNE REACTION OF THE BODY IN RESPONSE TO THE IMPLANT BEING TREATED AS A FOREIGN BODY. AS IT IS UNABLE TO ELIMINATE THE IMPLANT, THE BODY SURROUNDS IT WITH IMMUNE CELLS (MACROPHAGES) FORMING A MORE OR LESS HARD AND INFLAMMATORY MASS. A TREATMENT WITH HYALURONIDASE AND ANTI-INFLAMMATORIES GENERALLY ALLOWS TO TREAT THESE REACTIONS QUICKLY AND EFFECTIVELY, ALTHOUGH CERTAIN GRANULOMAS AT AN ADVANCED STAGE MIGHT BE UNRESPONSIVE TO HYALURONIDASE. THE RISK OF SUCH REACTION IS MENTIONED IN THE INSTRUCTIONS FOR USE OF TEOSYAL PRODUCTS. BATCH DATA REVIEW: THE BATCH DATA REVIEW WAS COMPLIANT WITH THE APPLICABLE SPECIFICATIONS. NO ELEMENT ALLOWS US TO IDENTIFY A DEFECT IN EITHER THE QUALITY OR THE SAFETY OF THIS TEOSYAL RHA 3 PRODUCT. BATCH DATA HISTORY: NO OTHER COMPLAINT WAS REGISTERED TO DATE (B)(6) 2022) WITH THIS BATCH NUMBER.

    Description of Event or Problem · 0

    THIS CASE OCCURRED OUTSIDE OF THE US, IN (B)(6). ACCORDING TO THE INFORMATION RECEIVED ON (B)(6) 2022, A PATIENT WAS INJECTED ON (B)(6) 2022, WITH THE FOLLOWING DERMAL FILLERS: -TEOSYAL PURESENSE REDENSITY 2 INTO THE TEAR TROUGH AREA (OBJECT OF THE COMPLAINT RC/2211084). -TEOSYAL RHA 2 INTO THE LIPS (OBJECT OF THE COMPLAINT RC/2211085). -TEOSYAL RHA 3 INTO THE BILATERAL NASOLABIAL FOLDS (OBJECT OF THIS COMPLAINT). -TEOSYAL RHA 4 INTO THE BILATERAL SUPERFICIAL FAT COMPARTMENT OF THE CHEEKS (OBJECT OF THE COMPLAINT RC/2211087). -TEOSYAL PURESENSE ULTRA DEEP INTO THE BILATERAL MANDIBULAR ANGLES AND ZYGOMATIC AREA (OBJECT OF THE COMPLAINT RC/2211088). APPROXIMATELY 2 MONTHS POST-INJECTION, THE PATIENT PRESENTED WITH A GRANULOMATOUS REACTION IN THE JAW AREA. AS A CORRECTIVE ACTION, HYALURONIDASE WAS INJECTED. ON NOV. 21, 2022, ANOTHER EPISODE OF INFLAMMATION AND GRANULOMATOUS REACTION ON BILATERAL CHEEKS AND MANDIBULAR ANGLES APPEARED. HYALURONIDASE, CORTICOSTEROIDS (DACORTIN 30 MG ONCE DAILY FOR 7 DAYS) WERE PRESCRIBED. ON (B)(6) 2022, A LOCAL MEDICAL EXPERT CONTACTED THE PRACTITIONER FOR MANAGEMENT OF THIS CASE. THE LATTER RECOMMENDED THE FOLLOWING TREATMENT: -ANTIBIOTIC (MOXIFLOXACIN 500 MG, CLARITHROMYCIN 400 MG TWICE A DAY, FOR 21 DAYS) -ANTI-INFLAMMATORY (GLUCOCORTICOID; DEFLAZACORT IN INCREASING DOSE FOR 2 WEEKS) -PROTON PUMP INHIBITOR (OMEPRAZOLE OR PANTOPRAZOLE), AND PROBIOTICS REVIEW THE PATIENT 5 DAYS AFTER THE START OF TREATMENT, AND INJECT THE NODULES WITH HYALURONIDASE (30-120 IU DEPENDING ON THE SIZE) SYMPTOM'S EVOLUTION IS MONITORED FOR THIS CASE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596306 TEOSYAL RHA 3 PATIENT RESTRAINT LMH TEOXANE SA TP27L-214822A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other