BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 15560275 · Received October 7, 2022

    Report

    Report Number
    3005975625-2022-00531
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    August 25, 2022
    Report Date
    October 7, 2022
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MFR NARRATIVE: 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 PRODUCT. BATCH HISTORY: NO OTHER COMPLAINT REGISTERED TO DATE FOR THIS BATCH NUMBER.

    Description of Event or Problem · 0

    THIS CASE OCCURED OUTSIDE OF THE USA, IN ITALY. ACCORDING TO THE INFORMATION RECEIVED ON 12 SEPTEMBER 2022, A PATIENT WAS INJECTED ON (B)(6) 2022 WITH A TOTAL OF 1 ML OF TEOSYAL RHA 4 (TPUL-220219C0) IN BOTH MARIONETTE LINES. THE INJECTOR USED THE SYRINGE PROVIDED IN THE BOX AND USED THE LINEAR RETROGRADE TECHNIQUE. APPROXIMATELY 3 MONTHS FOLLOWING THE INJECTION, ON (B)(6) 2022, THE PATIENT COMPLAINED ABOUT TWO ROUNDED FORMATIONS IN MARIONETTE LINES (BIGGER ON THE RIGHT SIDE THAN ON THE LEFT SIDE) ACCOMPANIED WITH HARDNESS TO THE TOUCH, HEAT AND MODERATE PAIN IN THAT AREA. ACCORDING TO THIS DESCRIPTION, THE INJECTOR DIAGNOSED THE ROUNDED FORMATIONS AS GRANULOMAS, EVEN IF NO ULTRASOUND WERE PERFORMED AS DIAGNOSTIC TOOL. DURING THE MEDICAL EXAMINATION, THE INJECTOR DIAGNOSED VIRAL INFECTION IN THE THROAT AND HERPES ZOSTER WITH RED SPOT ON THE CHEST. THUS, THE PATIENT WAS PRESCRIBED AN ANTIVIRAL TREATMENT (ACYCLOVIR 400MG ) FOR 10 DAYS: 3X/D FOR 4 DAYS, 2X/D FOR 3 DAYS, 1X/D FOR 3 DAYS. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH AN UNKNOWN DOES OF HYALURONIDASE IN THE TWO GRANULOMAS AND WAS PRESCRIBED AN ANTIBIOTIC (CEFIXORAL) FOR ONE WEEK. ON (B)(6) 2022, THE PATIENT RECEIVED A SECOND UNKNOWN DOSE OF HYALURONIDASE IN BOTH GRANULOMAS. A MEDICAL EXPERT HAS BEEN CONTACTED TO PROVIDE SUPPORT TO THE INJECTOR ON THIS CASE. HE RECOMMENDED TO TREAT THE PATIENT WITH HYALURONIDASE AND CORTICOID (DELTACORTENE 25MG). THE INJECTOR, SUPPORTED BY THE MEDICAL EXPERT, BOTH MENTIONED THAT THE VIRAL INFECTION ASSOCIATED WITH THE HERPES ZOSTER MIGHT HAVE CONTRIBUTED TO THE ONSET OF GRANULOMAS. ON (B)(6) 2022, THE INJECTOR PRESCRIBED DELTACORTENE 25 MG TO THE PATIENT. ON 29 SEPTEMBER 2022, WE WERE INFORMED THAT ALL THE SYMPTOMS WERE SOLVED FROM (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554598 TEOSYAL RHA 4 DERMAL FILLER LMH TEOXANE SA TPUL-220219C0

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other