BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE DEFYNE

    MDR report key: 18338924 · Received December 15, 2023

    Report

    Report Number
    9710154-2023-00088
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 11, 2023
    Report Date
    December 15, 2023
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029/S050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EXPECTED EVENT OF NODULE AT IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. THE SERIOUS EVENT OF OEDEMA AT IMPLANT SITE AND THE NON-SERIOUS EVENT OF ERYTHEMA AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS WITH RESTYLANE LYFT LIDOCAINE AND RESTYLANE DEFYNE AND UNEXPECTED AND UNRELATED TO THE TREATMENT WITH RESTYLANE VOLYME AS NO TREATMENT WAS PERFORMED IN THE AFFECTED AREAS. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES THE TREATMENT PROCEDURE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO THIS DATE, THIS IS THE ONLY MEDICAL COMPLAINT REPORTED FOR THIS LOT. A BATCH RECORD REVIEW WAS PERFORMED. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 22-NOV-2023 BY A PHYSICIAN, WHICH REFERS TO A 41-YEAR-OLD BROWN FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 23-NOV-2023 FROM THE SAME REPORTER. THE MEDICAL HISTORY OF THE PATIENT INCLUDED PSORIASIS. CONCOMITANT MEDICATIONS INCLUDED HUMIRA [ADALIMUMAB] 40 MG ONCE A MONTH FOR PSORIASIS STARTED IN 2014 (9 YEARS AGO FROM DATE OF REPORT). THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENTS WITH UNSPECIFIED HA FILLER AND SCULPTRA IN 2020 (3 YEARS AGO FROM DATE OF REPORT) WITH ANOTHER HEALTH PROFESSIONAL. ON AN UNKNOWN DATE IN (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE VOLYME TO MALAR AREA (UNKNOWN AMOUNT, LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 1 ML OF RESTYLANE LYFT LIDOCAINE (LOT 20627) TO CHIN USING NEEDLE WITH BOLUS INJECTION TECHNIQUE. SAME DAY, THE PATIENT ALSO RECEIVED TREATMENT WITH 1 ML OF RESTYLANE DEFYNE (LOT 20318-1), 0.5 ML TO EACH SIDE OF MARIONETTE LINES RENNOVA MICROCANNULA 22G X 50 MM AND 21 PUNCTURE NEEDLE WITH FAN INJECTION TECHNIQUE. ON (B)(6) 2023, THE PATIENT EXPERIENCED EDEMA (IMPLANT SITE OEDEMA), HARDENED NODULES (IMPLANT SITE NODULE), ABSENCE OF HEAT AND ERYTHEMA (IMPLANT SITE ERYTHEMA) AT CHIN AND MARIONETTE LINES. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH ALEKTOS [BILASTINE] 20 MG AND PREDSIM [PREDNISOLONE SODIUM PHOSPHATE] 40 MG AND THE PATIENT'S CONDITION WORSENED. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH 1200 UI OF HYALURONIDASE [HYALURONIDASE], 400 UI IN THE RIGHT LABIOMENTAL SULCUS (SLM) AND 800 UI IN THE LEFT LABIOMENTAL SULCUS. THE PHYSICIAN ALSO ADMINISTERED 0.1 ML (2 MG) OF TRIAMCINOLONE [TRIAMCINOLONE] DILUTED WITH HYALURONIDASE IN THE LEFT LABIOMENTAL SULCUS. ON (B)(6) 2023, THE PATIENT UNDERWENT BLOOD COUNT, EVHS, PCR, EAS (AS REPORTED) AND HEPATOGRAM TESTS AND ALL WERE UNREMARKABLE. ON (B)(6) 2023, THE HCP PERFORMED A DERMATOLOGICAL ULTRASOUND TO MAP THE PRODUCT ON THE FACE DIAGNOSTIC IMPRESSION. THE RESULT SHOWED: PRESENCE OF HYPOECHOIC, HETEROGENEOUS IMAGES, PERMEATED BY ANECHOIC AREAS, IN THE LEFT AND RIGHT SLM (AS REPORTED), SUGGESTIVE OF LATE NON-INFLAMMATORY NODULES RELATED TO A PREVIOUS AESTHETIC PROCEDURE. PRESENCE OF ANECHOIC, PSEUDO CYSTIC IMAGES, COMPATIBLE WITH FOCAL DEPOSITS OF HYALURONIC ACID, OF USUAL APPEARANCE TO THE ULTRASOUND METHOD, IN THE LEFT AND RIGHT SLM (AS REPORTED). ON (B)(6) 2023, AFTER THE ULTRASOUND EXAMINATION, 1000 UI OF HYALURONIDASE WAS INFILTRATED INTO THE EACH LABIOMENTAL SULCUS UNDER ULTRASOUND GUIDANCE. THE PATIENT WAS ADMINISTERED AGAIN WITH TRIAMCINOLONE 5 MG PER LABIOMENTAL SULCUS DILUTED IN HYALURONIDASE. ON (B)(6) 2023, THE PATIENT'S CONDITION DID NOT IMPROVE, AND ANOTHER 1000 UI OF HYALURONIDASE WAS APPLIED TO EACH LABIOMENTAL SULCUS AND 1000 UI TO THE CHIN NODULE ALONG WITH 0.2 ML OF 5 FU [FLUOROURACIL] WAS ADMINISTERED TO EACH LABIOMENTAL SULCUS. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ULTRASOUND, BUT THERE WAS STILL NO OFFICIAL REPORT ON THE IMAGES. THE PROFESSIONAL REPORTED THAT THE NODULES WITH A FOCUS OF HYALURONIC ACID STILL PERSISTED, AND THE PATIENT STILL EXPERIENCED HARDENED NODULES AND EDEMA. ON (B)(6) 2023, THE HCP APPLIED 4500 UI OF HYALURONIDASE TO EACH LABIOMENTAL SULCUS AND 4500 UI OF HYALURONIDASE TO EACH MALAR SIDE FOR THE FIRST-TIME. ON (B)(6) 2023, IN ADDITION TO HYALURONIDASE, HCP ADMINISTERED 0.2 ML OF 5 FU TO THE MALAR NODULES. ON (B)(6) 2023, THE PHYSICIAN PERFORMED AN ULTRASOUND WHICH STILL SHOWED THE PRESENCE OF HYALURONIC ACID AND NON-INFLAMMATORY NODULES. THE HCP APPLIED 4500 UI OF HYALURONIDASE TO EACH MALAR SIDE AND 3000 UI OF HYALURONIDASE TO EACH CHIN SULCUS. THE PHYSICIAN INFORMED THAT 5 HYALURONIDASE SESSIONS WERE PERFORMED AND TOTAL OF 39000 UI HYALURONIDASE WAS ADMINISTERED. THE PHYSICIAN INFORMED THAT THE PATIENT WAS STILL UNDERGOING TREATMENT, ALREADY IMPROVING, BUT STILL HAD PALPABLE NODULES. THE INJURY HAD WORSENED (NOT SPECIFIED), BUT AT THE MOMENT THERE WAS IMPROVEMENT, BUT THERE WAS NO INVOLUTION YET. THE PATIENT WAS NOT HOSPITALIZED DUE TO THE ADVERSE EVENTS. THE REPORTING HCP ASSESSED THE CAUSALITY AS UNLIKELY. OUTCOME AT THE TIME OF THE REPORT: EDEMA WAS RECOVERING/RESOLVING. HARDENED NODULES WAS RECOVERING/RESOLVING. ERYTHEMA WAS RECOVERING/RESOLVING. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON (B)(6) 2023 FROM THE SAME PHYSICIAN: RESTYLANE VOLYME WAS ALSO ASSESSED AS SUSPECT. DEVICE LOCATION OF RESTYLANE DEFYNE, LOCATION OF EVENT IMPLANT SITE, OUTCOME, LABORATORY DATA AND CORRECTIVE TREATMENT DETAILS WERE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929511 RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED 20318-1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention HUMIRA