BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2090865 · Received May 6, 2011

    Report

    Report Number
    2135225-2011-00037
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SYRINGES OF RADIESSE WERE USED FOR THE PT'S (B)(6) 2011 INJECTION. THE SECOND LOT IS AS FOLLOWS: CATALOG#: 8071M0K1, LOT#: 1022681, EXP DATE: 09/2012. FOR SECOND LOT, DEVICE MANUFACTURE DATE: 09/2012. THE PT HAD REPORTED TO THE INJECTOR THAT THE SWELLING, SINUS INFECTIONS AND REDNESS HAVE RESOLVED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOTS 1023083 AND 1022681 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 RADIESSE DERMAL FILLER ON (B)(6) 2011 IN THE NL FOLDS AND ALONG THE CHEEKBONES. THE PT INDICATED TO DR. (B)(6), THAT SHE HAD A SINUS INFECTION BEGINNING, AND LATER THAT DAY WENT TO HER PCP FOR ANTIBIOTICS. THE PT RETURNED FOR A FOLLOW-UP WITH DR. (B)(6) ON (B)(6) 2011; THERE WAS NO SWELLING, NO PAIN AND JUST SLIGHT REDNESS UNDER THE EYES. OVER THAT WEEKEND ((B)(6)) THE PT CALLED DR. (B)(6), INDICATING SHE HAD REDNESS AND WAS VERY SWOLLEN, MOSTLY IN THE RIGHT CHEEK. THERE WAS NO FEVER MENTIONED. DR. (B)(6) PRESCRIBED ANTIBIOTICS. THE FOLLOWING WEEK, THE SYMPTOMS HAD NOT SUBSIDED; THE PT WAS PRESCRIBED A STRONGER ANTIBIOTIC. BY THE (B)(6), THE SWELLING AND REDNESS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention