BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4895926 · Received July 1, 2015

    Report

    Report Number
    2135225-2015-00044
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    September 1, 2013
    Report Date
    June 9, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, IN (B)(6)2013, THE PATIENT HAD MRI, ULTRASONOGRAPHY AND LOCALLY DEXAMETHASONE (0.5 ML 15 DAYS). IN (B)(6) 2014, A BLEPHAROPLASTY WAS CARRIED OUT IN ORDER TO REMOVE THE PRODUCT AND SUPPOSED GRANULOMA. IN (B)(6) 2015, THE PATIENT HAD A RECURRENCE OF INFLAMMATORY REACTION IN THE SAME AREA. IN (B)(6) 2015-(B)(6) 2015, THE PATIENT HAD: "LOCALLY DEXAMETHASONE WITH GENTAMICIN NO20, LOCALLY LONGIDAZA, PER OS KLACID 500 MG TWICE A DAY - 5 DAYS, NIMESULIDE 100 MG TWICE A DAY - 10 DAYS, SUPRASTINEX, 5 MG A DAY, SUPPOSITORIES WITH POLIOXIDONIUM, 12 MG A DAY NO20. BEGINNING FROM JUNE ALL THE DRUGS WERE DISCONTINUED." MERZ REQUESTED THE HISTOLOGY STATEMENT BUT IT HAS NOT BEEN RECEIVED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE TO THE MID ZYGOMATIC AREA ON (B)(6) 2011. THE PATIENT WAS IN A SAUNA SIX WEEKS AFTER THE INJECTION. IN (B)(6) 2013, THE PATIENT DEVELOPED EDEMA, HYPEREMIA AND PAIN TO THE ZYGOMATIC REGION, INFERIOR EYELID REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426473 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA 1026339

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention