BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4990698 · Received August 7, 2015

    Report

    Report Number
    2135225-2015-00052
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    June 27, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD REVIEW FOR REPORTED LOT NUMBER WAS CONDUCTED. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED ON (B)(6) 2015 WITH 1.5CC OF RADIESSE TO THE NLF. TWO DAYS AFTER INJECTION, THE PATIENT'S NOSE BECAME DARK RED. SHE ALSO DEVELOPED PIMPLES ON HER NOSE. ON (B)(6) 2015, THE PATIENT WENT TO URGENT CARE. THE URGENT CARE PHYSICIAN SAID IT LOOKED LIKE PATIENT HAD AN INFECTION AND IT COULD BE AN ALLERGIC REACTION TO THE FILLER INJECTION OR SOME BACTERIA INTRODUCED BY THE NEEDLE. THE PATIENT WAS PRESCRIBED CEPHALEXIN 500 MG ORAL 3 TIMES DAILY AND MUPIROCIN CALCIUM (BACTROBAN) TOPICAL CREAM 3 TIMES DAILY. ON (B)(6) 2015, THE INJECTING PHYSICIAN INFORMED MERZ THAT HE SAW THE PATIENT AND SHE WAS BROKEN OUT WITH A RASH, REDNESS AND BUMPS TO THE RIGHT SIDE OF NOSE, BUT IT WAS NOT OVERLYING THE AREA THAT WAS INJECTED. IT WAS TO THE UPPER PART OF THE NOSE. PER THE PATIENT, THE INJECTING PHYSICIAN SAID HE HAD NEVER SEEN THIS BEFORE, THAT HE DID NOT INJECT NEAR THE NOSE. ON (B)(6) 2015, THE PATIENT NOTED THAT THE INFECTION WAS GONE AND A DARK AREA REMAINS WHERE THE INFECTION WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521167 RADIESSE DERMAL FILLER LMH MERZ NORTH AMERICA 100078475

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention