BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 13193961 · Received January 7, 2022

    Report

    Report Number
    3013840437-2022-00003
    Event Type
    Injury
    Date Received
    January 7, 2022
    Report Date
    January 7, 2022
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT FOREIGN BODY GRANULOMA (PT: INJECTION SITE GRANULOMA), WAS DEEMED TO MEET SERIOUS CRITERIA OF REQUIRED TREATMENT TO PREVENT PERMANENT DAMAGE AND DUE TO HOSPITALIZATION. THE DEVICE HISTORY RECORD OF BELOTERO BALANCE COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT REPORTED. BINGOEL, A., DASTAGIR, K., NEUBERT, L., OBED, D., HOFMANN, T., KREZDORN, N., KONNEKER, S., VOGT, P., METT, T. (2021). COMPLICATIONS AND DISASTERS AFTER MINIMALLY INVASIVE TISSUE AUGMENTATION WITH DIFFERENT TYPES OF FILLERS: A RETROSPECTIVE ANALYSIS. AESTH PLAST SURG. HTTPS://DOI.ORG/10.1007/S00266-021-02691-9

    Description of Event or Problem · 0

    THIS CASE WAS LINKED TO LSSMV CASES NUMBER 22-00007- 22-00009, REFERRING TO THE SAME LITERATURE ARTICLE. THIS IS A LITERATURE REPORT FROM A RETROSPECTIVE STUDY AIMED TO DELINEATE THE DIFFERENCES BETWEEN PERMANENT AND NON-PERMANENT FILLER COMPLICATIONS, TREATMENT OPTIONS AS WELL AS SALVAGE STRATEGIES IN SEVERE CASES OF FILLER COMPLICATIONS. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED PRESUMABLY WITH HYALURONIC ACID, INTO THE FACE. AS REPORTED, THE PATIENT ALSO HAD LIPOFILLING. THE PATIENT DID NOT AUTO INJECT. THE PATIENTS COMORBIDITIES WERE REPORTED AS NONE. AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED FOREIGN BODY INCLUSIONS IN THE FACE. HISTOPATHOLOGICAL WORKUPS SHOWED PRESUMABLE HYALURONIC ACID. SURGICAL THERAPY INCLUDED EXCISION OF THE FOREIGN BODY GRANULOMA OF THE LEFT PERIORBITAL AREA. THE PATIENT HAD 1 X RECURRENT GRANULOMA. THE PATIENTS LENGTH OF STAY IN THE HOSPITAL WAS 1 DAY. REPORTEDLY, SHE WAS HEALED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVED. IN THE OPINION OF THE AUTHORS, A STAGED THERAPY WITH WATCHFUL WAITING AND TOPICAL COOLING, STEROIDS AND ANTIBIOTICS WERE APPLICABLE IN MILDER SYMPTOMS. SEVERE INFECTIONS, SKIN BREAKDOWNS OR PERSISTENT GRANULOMA WERE JUSTIFYING INDICATIONS FOR SURGICAL TREATMENT. IN DEPENDENCE OF THE SOFT TISSUE QUALITY AND WOUND SITUATION, A PARTIAL CLOSURE OR OPEN WOUND THERAPY WAS POSSIBLY THE BEST CHOICE. EVEN IN SECONDARY HEALING CASES, AN AESTHETICALLY REASONABLE RESULT HAD THE POSSIBILITY TO BE ACHIEVED OR RECONSTRUCTED BY SECONDARY CORRECTIONS. HYALURONIC ACID AS A FILLER MATERIAL HAD THE POSSIBILITY TO BE PURCHASED IN MANY COUNTRIES WITHOUT PRESCRIPTION. THIS OPENED THE DOOR FOR AUTO-INJECTIONS OR INJECTIONS BY LAYPEOPLE AND UNDERLINED THE NECESSITY FOR LEGAL CONTROL OF THESE SUBSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623506 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Hospitalization| R CONCOMITANT DRUG NOT AVAILABLE