BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 13203608 · Received January 10, 2022

    Report

    Report Number
    3005975625-2021-00766
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    November 2, 2021
    Report Date
    January 10, 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

    CORRECTED DATA: FOLLOWING RECEIPT OF THIS COMPLAINT, THE (B)(6) SUBSIDIARY PUT THE INJECTOR IN CONTACT WITH A LOCAL MEDICAL EXPERT TO ADVISE ON THIS CASE.

    Description of Event or Problem · 0

    ACCORDING TO INFORMATION RECEIVED AS OF (B)(6) 2021, A FEMALE PATIENT WAS INJECTED ON (B)(6) 2021, WITH 1 ML OF TEOSYAL PURESENSE ULTRA DEEP (TSUL-210725A0) INTO THE BILATERAL MID-CHEEKS AND ZYGOMATIC AREAS (OBJECT OF THE COMPLAINT RC/2112076), WITH 2 ML OF TEOSYAL RHA 4 (TPUL-210427B0) INTO THE BILATERAL ZYGOMATIC AND ANTEROMEDIAL CHEEK REGIONS (OBJECT OF THIS COMPLAINT) AND WITH 1 ML OF TEOSYAL RHA 3 (TP27L-204416B0) INTO THE LIPS (OBJECT OF THE COMPLAINT RC/2112078). APPROXIMATELY 2 WEEKS POST-INJECTION ON (B)(6) 2021, THE PATIENT EXPERIENCED SOME DISCOMFORT AT THE INJECTION SITES, ACCOMPANIED BY MILD PAIN AND NEURALGIA. IT WAS REPORTED THAT DUE TO A STRESSFUL SITUATION DUE TO PERSONAL REASONS, AT THE SAME PERIOD (A FEW DAYS BEFORE (B)(6) 2021) THE PATIENT HAD DEEP VEIN THROMBOSIS (DVT) IN THE LOWER LIMBS, FOR WHICH SHE WAS ADVISED TO TAKE ACETYLSALICYLIC ACID (ADIRO) ALONG WITH A MICRONIZED PURIFIED FLAVONOID FRACTION (DAFLON). THE PATIENT UNDERWENT A DOPPLER ULTRASOUND ON (B)(6) 2021, BUT RESULTS WERE NOT PROVIDED. ON (B)(6) 2021, THE PATIENT WENT TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH FACIAL CELLULITIS AND NODULES ON THE PALPEBROMALAR GROOVE AND TEAR TROUGH AREAS. AS A CORRECTIVE ACTION, THE PATIENT RECEIVED A COMBINED ANTIBIOTIC TREATMENT (AMOXICILLIN/CLAVULANIC ACID; AUGMENTINE 875/125 MG 3X/ DAY DURING SEVEN DAYS) AND AN ANTI-INFLAMMATORY AGENT (IBUPROFEN 400 MG 3X/DAY DURING 3 DAYS). ON (B)(6) 2021, THE PATIENT RECEIVED THE NEW TREATMENT (ANTIBIOTIC; AMOXICILLIN (UNKNOWN DOSE) FOR 10 DAYS AND ANOTHER ANTI-INFLAMMATORY AGENT (GLUCOCORTICOID; URBASON 40 MG UNTIL (B)(6) 2021). FOLLOWING THIS INITIAL REPORT, THE SPANISH SUBSIDIARY PUT IN CONTACT THE INJECTOR WITH A LOCAL MEDICAL EXPERT TO ADVISE ON THIS CASE. THE EXPERT RECOMMENDED THE FOLLOWING TREATMENT: ANTIBIOTIC (AZITHROMYCIN + CIPROFLOXACINE), ACCOMPANIED BY CORTICOSTEROID (ZAMENE) FOR 21 DAYS. 5 DAYS AFTER THE START OF THE TREATMENT, INJECTION OF HYALURONIDASE. NO ADDITIONAL INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992667 TEOSYAL RHA 4 DERMAL FILLER LMH TEOXANE SA NOT APPLICABLE TPUL-210427B0

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other