BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 11717540 · Received April 23, 2021

    Report

    Report Number
    3013840437-2021-00111
    Event Type
    Injury
    Date Received
    April 23, 2021
    Report Date
    April 23, 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, SKIN NECROSIS (INJECTION SITE NECROSIS), 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: PARK, S.J., PARK, J.W., AHN, G.A., CHOI, S.Y., YOO, K.H., LI, K., & KIM, B.J. (2021). A STUDY OF THE MICROBIOLOGICAL PROFILE OF FILLER-INDUCED SKIN NECROSIS. CLINICAL AND EXPERIMENTAL DERMATOLOGY, THE EDUCATIONAL JOURNAL OF THE BRITISH ASSOCIATION OF DERMATOLOGISTS. DOI:10.1111/CED.14653.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00100, 3013840437-2021-00101, 3013840437-2021-00102, 3013840437-2021-00103, 3013840437-2021-00104, 3013840437-2021-00105, 3013840437-2021-00108, 3013840437-2021-00109, 3013840437-2021-00110, AND 3013840437-2021-00112, REFERRING TO THE SAME LITERATURE ARTICLE. THIS IS A LITERATURE REPORT FROM A RETROSPECTIVE STUDY AIMED TO DELINEATE THE BACTERIAL PROFILE AND PROGNOSTIC FACTORS OF FILLER-RELATED SKIN NECROSIS THROUGH A REVIEW OF THE CLINICAL AND MICROBIOLOGICAL FEATURES OF THE PATIENTS. THIS LITERATURE REPORT FROM THE REPUBLIC OF KOREA CONCERNS A (B)(6)-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, INTO THE NASOLABIAL FOLDS. IMMEDIATELY AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED BURNING AND BLANCHING. AS REPORTED, THE PATIENT ALSO EXPERIENCED PAIN AND A BLUISH COLOR, AND THE NASAL ALAR LOBULE WAS THE AFFECTED SITE. THREE DAYS AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT WAS INJECTED WITH HYALURONIDASE, AT ANOTHER HOSPITAL. AS REPORTED, THE PATIENT EXHIBITED SKIN SLOUGHING, SOFT TISSUE LOSS, OR ESCHAR. SKIN NECROSIS PROGNOSIS WAS EVALUATED USING THE TIME REQUIRED FOR COMPLETE EPITHELIALIZATION. THE PERIOD FROM FILLER INJECTION TO COMPLETION OF DAILY OCCLUSIVE DRESSING APPLICATION WAS ESTIMATED. DURATION OF THE EPITHELIZATION WAS UNKNOWN SINCE THE PATIENT WAS LOST TO A FOLLOW UP. THE EPITHELIALIZATION TIME WAS ASSUMED TO BE PROPORTIONAL TO DISEASE SEVERITY. THE PATIENT WAS GIVEN CIPROFLOXACIN IMMEDIATELY AFTER VISITING THE HOSPITAL. AS REPORTED, THE TREATMENT REGIMEN INCLUDED SUBLINGUAL NITROGLYCERIN TABLETS, HYPERBARIC OXYGEN, ANTIBIOTICS, DAILY OCCLUSIVE DRESSINGS, AND LIGHT-EMITTING DIODE THERAPY UNTIL EPITHELIZATION WAS COMPLETED. SWAB CULTURE WAS POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS, WHICH WAS COMMONLY DETECTED ON NORMAL HUMAN SKIN. THE PATIENTS LABORATORY DATA INCLUDED C-REACTIVE PROTEIN (CRP, 14 MG/L), ERYTHROCYTE SEDIMENTATION RATE (ESR, 67 MM/H), WHITE BLOOD CELL COUNT (WBC, 8570) AND NEUTROPHILS (NEU, 67.9%). THE OUTCOME OF THE EVENT WAS UNKNOWN. IN THE OPINION OF THE AUTHORS, THE FILLERS WERE NOT THE SOURCE OF THE INFECTIONS, BECAUSE DIFFERENT TYPES OF FILLERS WERE EMPLOYED, AND THE TIMING OF THE FILLER PRODUCTION WAS DIFFERENT. MOREOVER, MOST OF THE CULTURE ISOLATES WERE FOR BACTERIA ASSOCIATED WITH NOSOCOMIAL INFECTIONS, WHICH SUGGESTED THAT THE SOURCE OF INFECTION WAS A DEFECTIVE ASEPTIC PROCEDURE. THE CULTURE RESULTS SHOWED THAT NECROTIZED TISSUES WERE MORE SUSCEPTIBLE TO BACTERIAL INFECTIONS THAN EXPECTED. CULTURE POSITIVITY DID NOT SIGNIFICANTLY INFLUENCE EPITHELIALIZATION DURATION. THE INFLUENCE OF CULTURE POSITIVITY ON INFLAMMATORY MARKERS, SUCH AS ERYTHROCYTE SEDIMENTATION RATE AND C-REACTIVE PROTEIN, WAS NOT CONFIRMED. THE AUTHORS ASSUMED THAT DAMAGE TO THE LATERAL NASAL ARTERY OCCURRED FREQUENTLY WHEN FILLERS WERE INJECTED INTO THE NASOLABIAL FOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614269 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention