BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2132739 · Received June 9, 2011

    Report

    Report Number
    2135225-2011-00045
    Event Type
    Other
    Date Received
    June 9, 2011
    Date of Event
    February 25, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN DID NOT REPORT LOT NUMBER AND A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT ABLE TO BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN INJECTED A (B)(6) FEMALE WIT 1.5CC OF RADIESSE IN THE NASOLABIAL FOLDS AND MARIONETTE LINES ON (B)(6) 2010. THE PT DEVELOPED UNILATERAL INFLAMMATORY REACTION TWO MONTHS POST. AS A CORRECTIVE TREATMENT, THE PT RECEIVED CORTANCYL (PREDNISONE) 20MG BY ORAL ROUTE FOR 15 DAYS FROM (B)(6) 2011. AS OF (B)(6) 2011, THERE WAS NO IMPROVEMENT IN THE INFLAMMATORY REACTION. AS THE PHYSICIAN SUSPECTED INFECTIOUS COMPLICATIONS, SHE PRESCRIBED AUGMENTIN 1G X 3 DAILY ORAL ROUTE FOR 15 DAYS. THE ANTIBIOTIC THERAPY STARTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention