BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BASIC (INJECTION)

    MDR report key: 3021080 · Received March 13, 2013

    Report

    Report Number
    2135225-2013-00023
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CONSULT WITH MEDICAL AFFAIRS, IT WAS REPORTED THAT THE PHYSICIAN'S FATHER WHO IS A DERMATOLOGIST STATED THERE IS A SMALL AREA OF NECROTIC TISSUE PRESENT. NO INFORMATION REGARDING TREATMENT WAS PROVIDED. ATTEMPTS TO OBTAIN FOLLOW-UP INFORMATION HAVE BEEN PERFORMED HOWEVER, NO RESPONSES HAVE BEEN RECEIVED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED INJECTING A PATIENT (HER MOTHER) WITH BELOTERO ON (B)(6) 2013 IN THE VERTICAL LIP LINES, CHIN AREA AND THE MARIONETTE LINES. SHE DEVELOPED AN IMMEDIATE NODULE IN THE MARIONETTE REGION. SHE ATTEMPTED TO MASSAGE IT AWAY WITHOUT IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106336 BELOTERO BASIC (INJECTION) NONE LMH ANTEIS S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other