BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 12041059 · Received June 22, 2021

    Report

    Report Number
    3013840437-2021-00153
    Event Type
    Injury
    Date Received
    June 22, 2021
    Report Date
    August 23, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 18-AUG-2021: IT WAS CONFIRMED THAT THE PATIENT WAS NOT INJECTED WITH ANY COMPANY FILLERS. AS REPORTED HIGH-QUALITY CERTIFIED FILLERS FROM ANOTHER MANUFACTURER WERE USED. LIDOCAINE WAS NOT INCLUDED IN THE FILLERS. THE REPORTER CAUSALITY FOR THE EVENT WAS THEREFORE CHANGED FROM REASONABLE POSSIBILITY TO NOT RELATED.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE (PT: INJECTION SITE INFECTION), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED. LITERATURE CITATION: IKONNIKOVA EV, MANTUROVA NE, KRUGLOVA LS, POTKIN SB. COMPLICATION OF THREAD LIFTING IN FACIAL CONTOURING: A CLINICAL CASE RUSSIAN JOURNAL OF CLINICAL DERMATOLOGY AND VENEREOLOGY = KLINICHESKAYA DERMATOLOGIYA I VENEROLOGIYA. 2021;20(2):97-102. (IN RUSS.). HTTPS://DOI.ORG/10.17116/KLINDERMA20212002197.

    Description of Event or Problem · 1

    THIS LITERATURE REPORT FROM (B)(6) CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH HYALURONIC ACID, INTO THE CHEEKBONES (OFF LABEL USE OF DEVICE), FOR FILAMENT LIFTING DURING VOLUMETRIC CORRECTION. AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED AN ACUTE INFLAMMATORY REACTION. AN ULTRASOUND AND THE SCHEME OF THE THERAPY WAS PERFORMED. THE OUTCOME OF THE EVENT WAS UNKNOWN. IN THE OPINION OF THE AUTHORS, DESPITE THE FACT THAT THREAD LIFTING WAS CONSIDERED A RELATIVELY SAFE PROCEDURE IT HAD THE POSSIBILITY TO LEAD TO A NUMBER OF COMPLICATIONS BOTH IN THE FORM OF MONOTHERAPY AND BECOME A TRIGGER FOR THE DEVELOPMENT OF NEGATIVE PHENOMENA AT OTHER TREATMENT METHODS. FOLLOW-UP INFORMATION WAS RECEIVED ON 11-JUN-2021: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE WAS ADDED. THE EVENT ACUTE INFLAMMATORY REACTION WAS DELETED, IT WAS CONSIDERED TO BE A SYMPTOM OF THE LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH A TOTAL OF 2 ML OF HYALURONIC ACID, INTO THE CHEEKBONES AND LIPS. THE PATIENT WAS INJECTED WITH TWO DIFFERENT HYALURONIC ACID FILLERS, WITH 1.0 ML INTO THE AREA OF THE CHEEKBONES AND 1.0 ML INTO THE LIPS, FOR CONTOURING. AFTER THE PROCEDURE, THE PATIENT NOTED NO ADVERSE EVENTS OF ANY KIND. ONE MONTH AFTER THE CONTOURING PROCEDURE, THE PATIENT UNDERWENT THREAD LIFTING OF THE MIDDLE AND LOWER THIRD OF THE FACE (12 POLYDIOXANONE THREADS). APPROXIMATELY 1 MONTH AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT DEVELOPED INCREASING SWELLING, INFLAMMATION, REDNESS, PAIN, AND ITCHING OF THE MIDDLE THIRD OF THE FACE (THE CHEEKBONE AREA). REPORTEDLY, THESE EVENTS OCCURRED ON THE SECOND DAY AFTER PERFORMED THREAD LIFTING OF THE MIDDLE AND LOWER THIRD OF THE FACE. OBJECTIVE FINDINGS AT THE TIME OF EVALUATION (THIRD DAY AFTER THREAD LIFTING), THE PATIENT DISPLAYED PRONOUNCED SWELLING AND ERYTHEMA OF THE SKIN IN THE AREA OF THE MIDDLE THIRD OF THE FACE, EVENLY COMPACTED ON PALPATION. THE THREADS WERE NOT PALPABLE. THE ENTRY AND EXIT SITES WERE UNREMARKABLE, WITHOUT LOCAL INFLAMMATION OR PUS. NO PATHOLOGICAL CHANGES IN THE AREA OF THE LIPS. THE DIAGNOSIS WAS A LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE (UNSPECIFIED) AND AN UNSPECIFIED COMPLICATION OF PROCEDURE. TREATMENT INCLUDED AMOXICILLIN + CLAVULANIC ACID 875 MG/125 MG TWICE PER DAY FOR 10 DAYS, AND CETIRIZINE, 1 TABLET PER DAY. ON THE THIRD DAY OF TREATMENT, THE PATIENT SHOWED POSITIVE RESPONSE, PRACTICALLY COMPLETE REDUCTION OF SWELLING AND PAIN. HOWEVER, THE PATIENT CONTINUED TO COMPLAIN OF ITCHING. AN ULTRASOUND STUDY WAS PERFORMED. THE ULTRASOUND STUDY OF THE SKIN AND SOFT TISSUE OF THE CHEEKBONE, NASOLABIAL, CHEEK, AND LOWER JAW AREAS REVEALED LINEAR HYPERECHOGENIC INCLUSIONS IN THE SUBCUTANEOUS FATTY TISSUE, AT THE DEPTH OF 3.8-5.6 MM FROM THE SKIN SURFACE (AT LEAST 6 INCLUSIONS ON EACH SIDE), WITH CLEAR CONTOURS ON FLEXOGRAPHY, 0.18 MM THICK (CONSISTENT WITH THREAD IMPLANTS). ULTRASOUND ANGIOGRAPHY RESULTS, INCLUDING THE RESULTS OF ANGIOGRAPHY PERFORMED IN THE MICROCIRCULATION MODE, REVEALED NO ULTRASOUND SIGNS OF CHANGED BLOOD FLOW, LYMPHOSTASIS, OR INFILTRATIVE CHANGES IN THE TISSUES SURROUNDING THE THREADS AT THE TIME OF THE STUDY. AN ULTRASOUND STUDY OF THE SKIN AND SOFT TISSUE OF THE CHEEKBONE AREA (PENETRATING INTO THE SUBORBITAL AREA) REVEALED NUMEROUS ANECHOGENIC PRODUCT INCLUSIONS ON THE RIGHT AND LEFT, IN THE SUBCUTANEOUS FATTY TISSUE LAYER, AT THE DEPTH OF 2.4-3.5 MM FROM THE SKIN SURFACE, WITH CLEAR, EVEN CONTOURS AND MODERATELY HETEROGENEOUS STRUCTURE, 2.9 X 1.3 MM IN SIZE, WITHOUT CLEARLY VISIBLE BLOOD VESSELS OR INCREASED BLOOD FLOW, WITH HYPOECHOGENIC SECTIONS OF INFILTRATIVE INFLAMMATORY CHANGES LOCATED DEEPER, WITHOUT CLEAR CONTOURS, WITH MODERATELY HETEROGENEOUS STRUCTURE, 16.6 X 11.8 MM (ON THE LEFT) AND 8.2 X 5.4 MM (ON THE RIGHT) IN SIZE, WITHOUT PRONOUNCED INCREASED BLOOD FLOW, BASED ON THE RESULTS OF ULTRASOUND ANGIOGRAPHY PERFORMED IN THE MICROCIRCULATION MODE. AN ULTRASOUND STUDY OF THE SKIN AND SOFT TISSUE OF THE FACE IN THE UPPER LIP AREA REVEALED ISOLATED ANECHOGENIC PRODUCT INCLUSIONS WITH CLEAR, EVEN CONTOURS AND MODERATELY HETEROGENEOUS STRUCTURE, UP TO 1.6 MM IN DIAMETER ON THE RIGHT, 2.5 X 1.8 MM IN SIZE ON THE LEFT, WITHOUT SIGNS OF PATHOLOGICAL CHANGES. ON THE FIFTH DAY OF ANTIBIOTIC THERAPY, BASED ON ULTRASOUND RESULTS, THE TREATMENT STRATEGY WAS AUGMENTED WITH DEXAMETHASONE 2 MG ORALLY FOR 4 DAYS, FOLLOWED BY GRADUAL DOSE DECREASE. ADMINISTERED TREATMENT RESULTED IN RAPID REDUCTION OF REMAINING NEGATIVE SYMPTOMS. AT THE END OF TREATMENT, THE PATIENT UNDERWENT A FOLLOW-UP ULTRASOUND STUDY, WHICH REVEALED NO SIGNS OF INFLAMMATION. THE PATIENT REFUSED FILLER RESORPTION. NO SIDE EFFECTS WERE REPORTED DURING THE LONG-TERM OBSERVATION PERIOD (10 MONTHS). DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVED. IN THE OPINION OF THE AUTHORS, WHEN DIFFERENT METHODS WERE COMBINED TO CORRECT AESTHETIC SHORTCOMINGS, CERTAIN TYPES OF PROCEDURES MAY NOT ONLY BE THE MAIN CAUSE OF COMPLICATIONS, BUT MAY ALSO TRIGGER DEVELOPMENT OF SIDE EFFECTS WHEN COMBINED WITH PREVIOUSLY USED METHODS. THREAD LIFTING, AS THE TRAUMATIC FACTOR, INITIATED THE DELAYED INFLAMMATORY REACTION AT THE SITE OF FILLER INJECTED EARLIER. CAREFUL COLLECTION OF MEDICAL HISTORY AND MANDATORY PERFORMANCE OF OBJECTIVE EVALUATIONS (ULTRASOUND) WERE GOING TO HELP DETERMINE THE CORRECT DIAGNOSIS AND PRESCRIBE AN EFFECTIVE TREATMENT STRATEGY IN COMPLICATED DIAGNOSTIC SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937644 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention CONCOMITANT DRUG NOT AVAILABLE| CONCOMITANT DRUG NOT AVAILABLE