BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 11851920 · Received May 19, 2021

    Report

    Report Number
    3013840437-2021-00127
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, MULTISEPTATED ABSCESS FORMATION (DELAYED REACTION) (PT: INJECTION SITE ABSCESS STERILE), 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: SHIN, J.Y., CHAE, M.H., LEE, J.Y., YOON, T.Y., & KIM, M.K. (2019) A CASE OF STERILE ABSCESS INDUCED BY HYALURONIC ACID FILLER INJECTION. ANN DERMATOL, 31: S41-S43.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00126, REFERRING TO THE SAME PATIENT. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, INTO THE GLABELLA (INTENTIONAL DEVICE MISUSE). THE PATIENT HAD NO PREVIOUS FILLER INJECTION HISTORY. FIVE YEARS AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED A SLIGHTLY ERYTHEMATOUS, EDEMATOUS SWELLING ON HER GLABELLA. IT WAS FURTHER DESCRIBED AS A DELAYED REACTION OF HYALURONIC ACID. THERE WAS NO SIGN OF INFECTION SUCH AS LOCAL HEATING SENSE, REDNESS, PAIN, AND TENDERNESS. MULTISEPTATED ABSCESS FORMATION WAS OBSERVED ON THE PARANASAL SINUSES COMPUTED TOMOGRAPHY. IT SHOWED MULTISEPTATED LOW DENSITY LESION AT THE FOREHEAD AND DORSUM OF NOSE. HISTOPATHOLOGIC FINDINGS SHOWED SUPPURATIVE NECROSIS, CONTAINING MANY NEUTROPHILS MIXED WITH NECROTIC DEBRIS. GRAM, BROWN BRENN, D-PAS, AND AFB STAINS REVEALED NEGATIVE RESULTS. LABORATORY RESULTS SHOWED NEITHER LEUKOCYTOSIS NOR ELEVATED CRP LEVEL. THERE WAS NO BACTERIAL GROWTH ON THE PUS CULTURE. THE PATIENT WAS TREATED WITH AMOXICILLIN/CLAVULANATE AND PREDNISOLONE FOR 3 WEEKS WITH ASPIRATION, AND THE LESION HEALED COMPLETELY. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS WAS CONSIDERED AS RESOLVED. IN THE OPINION OF THE AUTHORS, IN THE PATIENT, THERE WAS A LACK OF CLINICAL OR LABORATORY RESULTS SUPPORTING AN INFECTION. THE LESION WAS NOT GOING TO HEAL WHEN TREATED WITH AMOXICILLIN/CLAVULANATE, IF THE ABSCESS WAS INDUCED BY A BIOFILM INFECTION. HYALURONIC ACID FRAGMENTS HAD THE POSSIBILITY TO ACT AS SUBSTRATES FOR CELL TRAFFICKING AND ACTIVATE MACROPHAGES, DENDRITIC CELLS, AND T CELLS. STERILE ABSCESS HAD THE POSSIBILITY TO BE FORMED THROUGH THAT IMMUNE REACTION. THEREFORE, IT WAS ESTABLISHED THAT THE LESION WAS MORE LIKELY TO BE A STERILE ABSCESS CAUSED BY AN IMMUNE REACTION OF HYALURONIC ACID, RATHER THAN BY A BIOFILM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743760 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention