BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1891310 · Received November 1, 2010

    Report

    Report Number
    2135225-2010-00079
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MFR DATE: 06/01/2010. LOT #1021247, CATALOG #8069M0K1, EXP DATE: 05/31/2012. THE DEVICE HISTORY RECORDS FOR RADIESSE LOTS 1020427 AND 1021247 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THESE LOTS.

    Description of Event or Problem · 1

    PHYSICIAN, WHO WAS ALSO THE PT, REPORTED THAT HE WAS INJECTED ON (B)(6) 2010 WITH 3.8 CC RADIESSE INJECTABLE IMPLANT IN THE NASOLABIAL FOLDS, MARIONETTE LINES, AND PRE-JOWL SULCUS. ON (B)(6) 2010, HE EXPERIENCED PAIN AND REDNESS AT THE ALAR TRIANGLE AND DOWN THE RIGHT NASOLABIAL FOLD, PAIN IN THE NOSTRIL AND "STUFFY FEELING" IN THE NOSE. INITIALLY, THERE WAS NO PALLOR OR BLANCHING AT THE SITE AND AS THE TIME PROGRESSED, DARKENING OF TISSUE WAS NOTED, NECROSIS WAS SUSPECTED. HE WAS TAKING ANTIBIOTICS (NAME NOT PROVIDED) AND WAS ON PREDNISONE FOR ANOTHER REASON. HE ALSO USED TOPICAL ANTIBIOTIC (NAME NOT PROVIDED) AND NITROPASTE INCLUDING HEAT AND MASSAGE TO THE AREA. STATED SITE LOOKED BETTER ALTHOUGH HE NOTED POSSIBLE SMALL SKIN SEPARATION AT ALAR TRIANGLE. VINEGAR RINSES WERE ALSO IMPLEMENTED. VASCULAR OCCLUSION DUE TO THE VOLUME OF PRODUCT PLACEMENT WITH SUPERFICIAL COMPRESSION OF VESSELS AS OPPOSED TO COMPRESSION OR OCCLUSION OF ONE PARTICULAR VESSEL WAS CONSIDERED. WOUND CARE REGIMEN CONSISTING OF VINEGAR SOAKS AND OCCLUSIVE OINTMENTS WAS RECOMMENDED AS TREATMENT ALONG WITH CONTINUED ANTIBIOTICS AND AN INCREASED PREDNISONE DOSAGE DUE TO POSSIBLY EXPERIENCING SYMPTOMS C/W INFRAORBITAL NERVE PARASTHESIA. ON (B)(6) 2010, THE PT STATED THAT THE NECROTIC TISSUES ARE SLOUGHING OFF THE INSIDE OF THE RIGHT NOSTRIL. THEY ARE HARD CREAM COLORED AND ARE DRIED BLOOD TINGED. THE RIGHT ALAR ASPECT OF THE NOSE IS CHANGING ITS SHAPE; IT IS LOOSING ITS VOLUME AND BECOMING THINNER AND MORE CONCAVE. ON (B)(6) 2010, THE PT APPEARS TO BE IMPROVING GRADUALLY. HE CONTINUES THE USE OF OINTMENTS, SALINE NASAL SPRAY, FREQUENT SHOWERS, PROPHYLACTIC ANTIBIOTICS AND HEAD ELEVATION AS TREATMENT. THE USE OF VALTREX WAS RECOMMENDED IF ANY WORSENING OF HIS CONDITION OCCURS. ON (B)(6) 2010, STATUS UPDATE RECEIVED FROM THE INJECTOR; THE PHYSICIAN "LOOKS GOOD, JUST A SMALL PURPLE SPOT AT THE RIGHT ALAR TRIANGLE. HE SAID HE IS STILL HAVING A LITTLE DRAINAGE FROM THE NOSTRIL BUT OTHERWISE IS HEALING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.) 1020427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention