BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1658689 · Received April 9, 2010

    Report

    Report Number
    2135225-2010-00016
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 11, 2010
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED A TENDER, RED, SWOLLEN AREA OVER THE RIGHT CHEEK THREE DAYS POST-INJECTION. SHE WAS TREATED WITH A 5-DAY COURSE OF ANTIBIOTIC, AUGMENTIN FOR POSSIBLE INFECTION, WHICH SHE RESPONDED TO. THE FOLLOWING WEEK, SHE DEVELOPED THE SAME SYMPTOMS IN THE LEFT CHEEK AREA. SHE WAS TREATED WITH A 10-DAY COURSE OF AUGMENTIN. DURING FOLLOW-UP WITH PHYSICIAN ON (B) (6) 2010, THE PATIENT HAD COMPLAINED OF BLOODY STOOLS AND URINARY FREQUENCY. THE PATIENT IS PLANNING TO SEE HER FAMILY PHYSICIAN ON (B) (6) 2010 AND WILL BE EVALUATED FOR THESE SYMPTOMS ALONG WITH ENDOCARDITIS. LATER FOLLOW-UP WITH PHYSICIAN REPORTED, THE PATIENT'S BLOODY STOOLS AND CHILLS WERE MOST CONSISTENT WITH ANTIBIOTIC ASSOCIATED DIARRHEA AND HAVE SINCE RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1014252 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE CHEEK AREAS ON (B) (6) 2010. THREE DAYS LATER, SHE DEVELOPED A TENDER, RED, SWOLLEN AREA OVER THE RIGHT CHEEK. THE PHYSICIAN PRESUMED AN INFECTION WAS PRESENT AND TREATED THE PATIENT WITH ANTIBIOTIC, AUGMENTIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1014252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention