BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 16086080 · Received December 30, 2022

    Report

    Report Number
    MW5114125
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    August 30, 2019
    Report Date
    December 29, 2022
    Manufacturer
    MERZ AESTHETICS GMBH
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED BELOTERO INJECTION TO BILATERAL TEAR TROUGHS. RESULTED IN FESTOON LIKE SWELLING UNDER BOTH EYES. REQUIRED TWO SEPARATE INJECTIONS OF HYLANEX AND ONE ADDITIONAL OF VITRASE TO ATTEMPT TO MITIGATE. RIGHT EYE RESOLVED AFTER INJECTIONS. LEFT EYE CONTINUES TO HAVE A AREA IN TEAR TROUGH THAT IS EDEMATOUS AND BUBBLE LIKE IN APPEARANCE 3 YEARS POST. RECEIVED BELOTERO INJECTION AT (B)(6). LOT NUMBER 321350, EXPIRATION 5/9/2020. I HAVE MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765950 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ AESTHETICS GMBH 321350

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention METFORMIN 750 MG, HS SERTRALINE 75 MG, QD MONTELUKAST 10 MG PRN.