BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOTERO

    MDR report key: 3592706 · Received January 9, 2014

    Report

    Report Number
    2135225-2013-00112
    Event Type
    Other
    Date Received
    January 9, 2014
    Date of Event
    October 26, 2013
    Report Date
    December 10, 2013
    Manufacturer
    ANTEIS, S.A.
    Product Code
    LMH
    PMA / PMN Number
    P90016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE BELOTERO LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.

    Description of Event or Problem · 1

    A DOCTOR WHO IS THE PT CALLED MERZ NORTH AMERICA, INC TO REPORT THAT SHE WAS INJECTED ON (B)(6) 2013 BY DR (B)(6) AT (B)(6). THE PT HAS BEEN INJECTED WITH FILLERS BEFORE BUT THIS WAS THE FIRST TIME THAT SHE WAS INJECTED WITH BELOTERO. IT WAS INJECTED ON THE RIGHT SIDE ONLY OF THE ORBITAL AREA TO FILL IN AN AREA THAT HAD FAT HERNIATION. SHE HAD A REACTION AND THERE WAS A LITTLE BIT OF SWELLING. STEROIDS WERE PRESCRIBED AND THE SWELLING WENT DOWN. THEN THE SWELLING CAME BACK AND DURING THE DAY THE SWELLING WOULD GO UP AND DOWN. FROM THE TEAR DUCT DOWN SHE DEVELOPED A STREAK. X-RAYS WERE TAKEN AND IT WAS THOUGHT TO BE AN INFECTION. ON (B)(6) 2013 SHE WAS HOSPITALIZED AND GIVE IV ANTIBIOTICS (ROCEFIN, DOSE AND DURATION NOT PROVIDED). SHE HAD A REACTION TO THE ROCEFIN AND WAS GIVEN A HIGH DOSE OF STEROIDS (SOLUMEDROL). SHE WAS PUT ON ZYBOX FOR 10 DAYS AND THEN LEVAQUIN FOR 10 DAYS AND EVERYTHING WAS UNDER CONTROL. THE INJECTED AREA THEN BECAME PUFFY AND IT BURNS INSIDE (PER THE PT). ON (B)(6) 2013, SHE SAW HER MAXILOFACIAL SURGEON, DR (B)(6), (B)(6),(SHE IS AN INJECTOR BUT HAS NOT USED BELOTERO). SHE SUGGESTED THAT THE PT GO BACK TO THE INJECTOR IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17821 BELOTERO INJECTABLE GEL LMH ANTEIS, S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization