BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1908967 · Received November 17, 2010

    Report

    Report Number
    2135225-2010-00081
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. (B)(6) SPOKE WITH (B)(6) CONSULTING PHYSICIAN DR. (B)(6) TO DISCUSS TREATMENT PLAN. AT ONE WEEK POST INJECTION, THE TREATMENT WOULD BE THE SAME TO PREVENT FURTHER DAMAGE TO THE SKIN. DR. (B)(6) AGREED WITH CONTINUING THE (B)(6) 2010, IT WAS INDICATED THAT THE PT IS BETTER. THE RADIESSE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PT INJECTED WITH RADIESSE DERMAL FILLER IN THE NL FOLDS ON (B)(6) 2010; NO BLANCHING WAS NOTED BY DR. (B)(6). TWO DAYS LATER ((B)(6) 2010), THE PT CONTACTED (B)(6) AND WAS SEEN BY ANOTHER PHYSICIAN. HE NOTED PAIN AND ERYTHEMA, SINGLE SIDED, NEAR THE NASAL ALA. THE PT WAS PRESCRIBED CORTISONE CREAM. ON (B)(6) 2010, DR. (B)(6) SPOKE WITH THE PT AND PRESCRIBED ORAL ANTIBIOTICS. THAT EVENING, THE PT WENT TO THE ER, SINCE THE PAIN WORSENED. THERE THE PT WAS ALSO PRESCRIBED ACYCLOVIR AND ORAL STEROIDS, BUT COULD NOT PICK UP PRESCRIPTION YET (AS OF NOON ON SUNDAY, (B)(6)). DR. (B)(6) SAW THE PT ON (B)(6) 2010 AND NOTED A SMALL DARK AREA BESIDE HER NOSE, WHICH ALSO APPEARS TO BE NECROTIC. HE PRESCRIBED NITROPASTE, NO SMOKING AND TAKE ASPIRIN FOR PAIN. HE ALSO RECOMMENDED TO CONTINUE THE ANTIBIOTICS AND ANTIVIRAL. DR. (B)(6) ALSO RECOMMENDED THAT THE PT SEE AN INTERN FOR COAGULATION WITH LOVENOX, BUT INTERN FEELS IT IS TOO RISKY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention