BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4895925 · Received July 1, 2015

    Report

    Report Number
    2135225-2015-00043
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    PKY
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NODULE WAS REMOVED PER EXCISION AND SENT FOR HISTOLOGICAL EXAMINATION WHICH SHOWED CRUMBLES OF WHITE SUBCUTANEOUS MATERIAL. PLASTIC RECONSTRUCTION OF THE DEFECT WAS PERFORMED. SYSTEMATIC ANTIBIOTICS WERE NOT PRESCRIBED TO TREAT THE EVENT. THE PATIENT RECOVERED. ON (B)(6) 2015, THE PHYSICIAN STATED THAT THE EXCISION OF THE NODULE WAS DUE TO MEDICAL NECESSITY. THE NODULE WAS CAUSING PRESSURE AND THE PHYSICIAN NEEDED A HISTOLOGICAL EXAMINATION TO EXCLUDE A NEOPLASIA. A SCAR REMAINED IN THE NASOLABIAL FOLD AND IS BARELY VISIBLE DUE TO THE LOCATION. THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED SUBCUTANEOUSLY WITH A TOTAL OF 0.25 ML OF RADIESSE INTO THE LEFT NASOLABIAL FOLD FOR ELASTORRHEXIS ON (B)(6) 2011. THE NEEDLE USED TO INJECT RADIESSE WAS A 24G CANNULA. IN (B)(6) 2015 THE PATIENT EXPERIENCED FORMATION OF AN ASEPTIC NODULE ON THE LEFT CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426380 RADIESSE DERMAL FILLER INJECTABLE IMPLANT PKY MERZ NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention