BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 5006573 · Received August 12, 2015

    Report

    Report Number
    2135225-2015-00055
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, A (B)(6)FEMALE PT WAS INJECTED WITH 1CC OF BELOTERO TO THE LIPS. ON (B)(6) 2015, THE PT PRESENTED TO THE OFFICE OF THE INJECTOR ((B)(6)) WITH A SMALL RED NODULE ON HER RIGHT CHEEK THAT WAS APPROXIMATELY 1 CM IN DIAMETER, SLIGHTLY RED, FIRM AND TENDER TO TOUCH. THE PT HAD A TEMPERATURE OF 99. SOME ACNE WAS NOTED. THE LIPS WERE OOZING BELOTERO. (B)(6) BELIEVED THE PT HAD AN INFECTION IN HER LIPS CAUSING THE CHEEK TO BE INFECTED. THE PT'S LIPS LOOKED FINE ASIDE FROM SOME SWELLING. THE PT "HAS BEEN TAKING ASPIRIN LAST NIGHT AND THIS MORNING". ON 07/16/2015, THE PT RECEIVED AN INJECTION OF ROCEPHIN AND WAS STARTED ON ORAL CLINDAMYCIN 150MG THREE TIMES DAILY. CULTURES WERE DONE OF PT'S LIP AND WERE NEGATIVE. THE PT FINISHED THE CLINDAMYCIN AND THE NODULE RESOLVED. THE DEVICE HISTORY RECORDS FOR THE INJECTED LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531144 BELOTERO BALANCE INJECTABLE IMPLANT LMH MERZ NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention