BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 1

    MDR report key: 13592081 · Received February 24, 2022

    Report

    Report Number
    3005975625-2022-00053
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    January 15, 2022
    Report Date
    February 24, 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: DATA BATCH HISTORY: 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 1 PRODUCT. DATA BATH HISTORY: NO OTHER COMPLAINT WAS REGISTERED TO DATE ((B)(6)2022) WITH THIS BATCH NUMBER.

    Description of Event or Problem · 0

    ACCORDING TO INFORMATION RECEIVED AS OF JAN. 27, 2022, A PATIENT WAS INJECTED ON (B)(6)2022, WITH 0.3 ML OF TEOSYAL RHA 1 (TPRL-210325B0) INTO THE VERTICAL LINES OF THE GLABELLA AREA. FOUR DAYS POST-INJECTION THE PATIENT WAS DIAGNOSED WITH A VASCULAR COMPRESSION. AS A CORRECTIVE ACTION, THE PATIENT RECEIVED THE FOLLOWING TREATMENT: ON (B)(6) 2022: 450 IU DOSE OF HYALURONIDASE, ALONG WITH NITROGLYCERIN (NG), ANTIBIOTIC CO-AMOXICLAV (AMOXICILLIN/CLAVULANIC ACID) AND ANTI-INFLAMMATORY MEDICATION (CORTICOSTEROIDS) ON (B)(6) 2022, ANOTHER DOSE OF 450 IU OF HYALURONIDASE AND MASSAGE ON (B)(6) 2022 THE PATIENT WAS REVIEWED BY THE INJECTOR, WHO ATTESTED TO AN IMPROVEMENT IN THE COLORING OF THE LESIONS AND A RE-PERMEABILIZATION OF THE VASCULARIZATION ON THE AFFECTED AREA. THE PATIENT NO LONGER NEEDED TO TAKE THE CORTICOSTEROID TREATMENT, ONLY THE ANTIBIOTIC AND A COMPLEMENTARY TREATMENT OF RESTAURANTE NEOVIDERM CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224843 TEOSYAL RHA 1 DERMAL FILLER LMH TEOXANE SA TPRL-210325B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other