BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 10590001 · Received September 25, 2020

    Report

    Report Number
    3013840437-2020-00079
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    April 27, 2021
    Manufacturer
    ANTEIS SA
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 07-APR-2021: THE AUTHOR CONFIRMED THAT NO COMPANY PRODUCT WAS USED, AND THAT THE PRODUCT USED WAS WITH LIDOCAINE. THE REPORTER CAUSALITY 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, NASAL SKIN NECROSIS, WAS DEEMED TO MEET THE 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. CITATION: VIEIRA MG, MACHADO-FILHO DA, ALCANTARA AR, MENDONÇA A, KIM JH, CORTES ARG. CLINICAL MANAGEMENT OF NASAL SKIN NECROSIS CAUSED BY HYALURONIC ACID FILLER. J CRANIOFAC SURG. 2020 AUG 13. DOI: 10.1097/SCS.0000000000006847. EPUB AHEAD OF PRINT. PMID: (B)(6).

    Description of Event or Problem · 1

    THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6)-YEARS-OLD FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, BY A DERMATOLOGIST, FOR NOSE AUGMENTATION PROCEDURE. AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT DEVELOPED A NASAL SKIN NECROSIS. THE TREATING DERMATOLOGIST ATTEMPTED TO TREAT THE COMPLICATION WITH LOW POWERED LASER 5 DAYS BEFORE PATIENT'S INITIAL ATTENDANCE AT THE CLINIC. THE PATIENT PRESENTED TO THE AUTHORS CLINIC WITH A HISTORY OF PERSISTENT PAIN. IN THE FIRST CLINICAL APPOINTMENT, INITIAL ANAMNESIS AND PHOTOGRAPHIC DOCUMENTATION WERE TAKEN. A NECROTIC SKIN AREA WITH DISCOLORATION, TENDERNESS, PARAESTHESIA AND PAIN EXTENDED FROM THE NOSE TIP TO THE RIGHT UPPER LIP. FOR CORRECTIVE TREATMENT, THE AUTHORS USED 2000 IU OF HYALURONIDASE, RESULTING IN A CONCENTRATION FOUR TIMES HIGHER THAN THE DESCRIBED IN THE LITERATURE. THE PATIENT WAS TREATED WITH THREE DOSES OF HYALURONIDASE APPLIED IN THE SAME DAY (A TOTAL OF 6000 IU) WITH CANNULA G22 UNDER ANESTHESIA OF THE INFRATROCHLEAR AND EXTERNAL NASAL NERVE, AS WELL AS OF THE AREA AROUND THE CANNULA WITH MEPIVACAINE WITHOUT ADRENALINE. HYALURONIDASE WAS THEN APPLIED AT THE NASAL DORSUM, WITH RETRO-INJECTIONS AND ROTATING THE CANNULA. ADDITIONAL APPLICATIONS AT THE COLUMELLA AND NASAL SPINE REGION WERE ALSO PERFORMED. TWO HOURS IMMEDIATELY AFTER PROCEDURE, ANOTHER APPLICATION WAS PERFORMED WITH CANNULA AND NEEDLE TO APPLY ON SUPERFICIAL NASAL TISSUES. NO PAIN WAS REPORTED BY THE PATIENT DURING THIS PROCEDURE, FACILITATING NEEDLE APPLICATION. NO IMMEDIATE CHANGES IN SKIN COLOUR OR SYMPTOMS WERE NOTED AFTER THE PROCEDURE, AND THE PATIENT WAS DISMISSED. POST-OPERATIVE PRESCRIPTIONS AND PROCEDURES WERE RECOMMENDED TO THE PATIENT. THESE INCLUDED CEPHALEXIN (500MG), 6H IN 6H PER 7 DAYS (AS REPORTED), METRONIDAZOLE (400MG), 8H IN 8H PER 7 DAYS, PREDNISOLONE (40MG), 12H IN 12H PER 5 DAYS, TOPICAL NITROGLYCERIN, ALL OVER THE REGION 2 TIMES A DAY, PENTOXIFYLLINE (400MG), 12H IN 12H PER 3 DAYS, ASPIRIN (100MG), 12H IN 12H PER 3 DAYS. FOLLOW-UP CONDITIONS WERE GRADUALLY IMPROVED. ON THE SIXTH DAY OF FOLLOW-UP, THE PATIENT RETURNED WITH NO SYMPTOMS AND FLESH NOSE SKIN ASPECT. DUE TO PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVED. IN THE OPINION OF THE AUTHORS, DESPITE PREVIOUS STUDIES HAVE DESCRIBED LOWER DOSES OF HYALURONIDASE (FROM 150 IU TO 1500 IU) AS SUFFICIENT, A HIGHER DOSE OF HYALURONIDASE (6000 IU) COULD ALSO BE USED EFFICIENTLY TO TREAT PRESSURE SKIN NECROSIS. A HIGH DOSE OF HYALURONIDASE APPLIED TO COMPENSATE OF TREATMENT DELAY (5 DAYS). KNOWLEDGE AND FAMILIARITY WITH THE PREVENTION, PRESENTATION, AND IMMEDIATE TREATMENT OF THE ADVERSE EVENTS IS ESSENTIAL FOR ATTAINING THE BEST POSSIBLE OUTCOME. THE AUTHORS FINDINGS SUGGEST THAT NASAL SKIN NECROSIS DUE TO EXCESSIVE AMOUNT OF HYALURONIC ACID FILLERS CAN BE EFFICIENTLY TREATED WITH HIGH DOSES OF HYALURONIDASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054292 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS SA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention CONCOMITANT DRUG NOT AVAILABLE.