BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOTERO BALANCE (INJECTION)

    MDR report key: 3143203 · Received May 28, 2013

    Report

    Report Number
    2135225-2013-00071
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CONSULT WITH MEDICAL AFFAIRS, IT WAS REPORTED THE TREATMENTS PROVIDED BY THE PHYSICIAN WERE OPTIMAL AND THE PT IS DOING WELL WITH MINIMAL TISSUE BREAKDOWN. FURTHER TREATMENTS USING VITRASE AND LOCAL WOUND CARE INCLUDING VINEGAR SOAKS AND OCCLUSIVE OINTMENTS WERE PERFORMED. DURING FOLLOW-UP THE PHYSICIAN REPORTED THE PT IS DOING WELL AT THIS TIME. THE SKIN REMAINED INTACT WITH A SMALL AREA OF REDDISH TISSUE. THE PT HAD MINIMAL TISSUE BREAKDOWN AND IS BEING SEEN WEEKLY. SHE ALSO REPORTED PRESCRIBING A MEDROL DOSE PACK FOR THE PT. THE DEVICE HISTORY RECORDS FOR LOT #321110 WERE REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THE PT WAS INJECTED WITH 0.3 CC OF BELOTERO IN THE GLABELLA ON (B)(6) 2013. SHE EXPERIENCED BLANCHING DURING THE INJECTION AND THE PHYSICIAN IMMEDIATELY STOPPED THE INJECTION AND TREATED HER WITH NITRO PASTE, VITRASE AND WARM COMPRESSES. SHE ALSO PRESCRIBED THE ANTIBIOTIC, DOXYCYCLINE AND RECOMMENDED SHE TAKE ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233345 BELOTERO BALANCE (INJECTION) INJECTABLE GEL LMH ANTEIS S.A. 321110

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention