BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3982915 · Received July 11, 2014

    Report

    Report Number
    2135225-2014-00046
    Event Type
    Other
    Date Received
    July 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTIVE TREATMENT INCLUDED CEFUROXIME, CEFTRIAXONE AND CLARITHROMYCIN. FURTHER INFORMATION WAS REQUESTED BUT NONE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT RECEIVED VIA CUSTOMER SERVICE FROM A (B)(6) PHYSICIAN CONCERTS A (B)(6) PATIENT, DEMOGRAPHICS UNKNOWN. SHE WAS TREATED WITH RADIESSE FOR FILLING IN GLUTEUS ABOUT 9 MONTHS AGO. PHYSICIAN REPORTS THAT AFTER THE PROCEDURE THE PATIENT HAD HARDENED AND DEEPER NODULES. SURGICAL DRAINAGES WERE PERFORMED WITHOUT SUCCESS. THE HOLES (FISTULAS) HAVE APPEARED 3 MONTHS AGO. (B)(6) INFECTION WAS OBSERVED AFTER SECRETION CULTURE. CORRECTIVE TREATMENT INCLUDED CEFUROXIME, CEFTRIAXONE AND CLARITHROMYCIN. THE OUTCOME OF THE EVENT WAS NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. THE PHYSICIAN REPORTER WAS NOT RESPONSIBLE FOR THE APPLICATION OF RADIESSE, IN THIS WAY IT WAS NOT POSSIBLE COLLECT THE DATA FROM THE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407856 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR