BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3142267 · Received May 22, 2013

    Report

    Report Number
    2135225-2013-00047
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE REPORTED RADIESSE LOT 1027609 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS COMPLAINT WAS FORWARDED BY (B)(4). ON (B)(6) 2013, DR. (B)(6) INJECTED THE PT WITH RADIESSE IN THE NOSE. THE PT EXPERIENCED NECROSIS. ON (B)(6) 2013, FOLLOW-UP INFORMATION WAS RECEIVED FROM (B)(4). THE PT WAS INJECTED ON (B)(6) 2013, WITH 0.3ML OF RADIESSE IN THE NOSE. SHE DEVELOPED NECROSIS IN THE NOSE. DATE OF ONSET: (B)(6) 2013. THE FOLLOWING MEASURES WERE TAKEN: ON (B)(6) 2013, THE PT WAS PRESCRIBED WITH SILVERDERMA POMADE (2/DAY) AND ORBEMIN 500MG TWICE A DAY AND PHOTOPROTECTION. THE PT IMPROVED ABOUT 10 - 15 DAYS LATER BUT STILL PRESENTS PINKISH EPIDERMIS AND SENSITIVITY TO THE AREA. THE OUTCOME OF NECROSIS IS DESCRIBED AS RESOLVED. THE PINKISH EPIDERMIS WHICH IS DESCRIBED AS "BURN" IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226155 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC 1027609

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention