BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2132472 · Received June 13, 2011

    Report

    Report Number
    2135225-2011-00058
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE PRACTITIONER SPOKE WITH MEDICAL AFFAIRS CONSULTANT, (B)(4). THEY REVIEWED THE POSSIBILITY THAT THE DENTAL WORK MAY HAVE CAUSED THE RADIESSE PRODUCT TO MIGRATE, FORMING A SOFT LUMP. A COPY OF THE PUBLISHED ARTICLE (B)(4) WAS PROVIDED (VIA (B)(4)) TO THE NURSE. IT MAY BE THAT THE LARGE ACCUMULATION OF PRODUCT IS CAUSING SOME LOCAL IRRITATION AS A RESULT OF THE GEL CARRIER. (B)(6) WILL CONTINUE TO MONITOR CLOSELY ON THE ANTIBIOTICS AND MAY TRY THE LIDO INJECTION IN AN EFFORT TO DISPERSE THE PRODUCT. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1024568 WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE; THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED WITH 1.5CC OF RADIESSE DERMAL FILLER TO THE MID-FACE, USING A BOLUS INJECTION. TWO DAYS LATER, THE PT WENT TO THE DENTIST FOR BRIDGE REMOVAL; THE PT FEELS SHE DEVELOPED AN INFECTION. HER DENTIST PRESCRIBED CLINDA 250 QID AND THE PT NOTED SOME IMPROVEMENT IN THE REDNESS. ON (B)(6) 2011, ABOUT ONE MONTH POST RADIESSE INJECTION, THE PT HAD A F/U APPOINTMENT WITH (B)(6). (B)(6) NOTED A SOFT, RED, TENDER LUMP TO HER RIGHT CHEEK, ABOUT 1 INCH DIAMETER. THE PT DID NOT COMPLAIN OF FEVER. (B)(6) PLACED THE PT ON TETRACYCLINE AS AN ADJUNCT TO THE CLINDA (PRESCRIBED BY THE DENTIST) IN CASE THIS WAS SOME SORT OF ATYPICAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1024568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention