BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 1003018 · Received February 25, 2008

    Report

    Report Number
    2135225-2008-00013
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 22, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT RETURNED TO DR AND WAS PRESCRIBED ORAL ANTIBIOTIC, CIPRO. PATIENT THEN WENT TO HOSPITAL AND WAS ADMITTED FOR 2-3 DAYS. HE WAS TREATED WITH IV ANTIBIOTICS; TOBRAMYCIN, VANCOMYCIN AND RELEASED WITH ORAL ANTIBIOTIC PRESCRIPTION; LEVAQUIN. PATIENT IS REPORTED TO BE HEALING AND MAY HAVE A SMALL SCAR REMAINING. RADIESSE INJECTIONS OF THE EAR AND NOSE ARE CONSIDERED TO BE OFF-LABEL USES. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOT #1006711, MET ALL SPECIFICATIONS. DR DID CULTURE THE INFECTION AND IT WAS DETERMINED TO BE ENTEROBACTER. DUE TO THE NATURE OF THE BACTERIA FOUND AND THE FACT THAT THERE WAS NO INFECTION PRESENT AT THE OTHER 2 INJECTIONS SITES, DR DID NOT FEEL THIS EVENT WAS PRODUCT RELATED.

    Description of Event or Problem · 1

    REPORTER REPORTED A PATIENT WHO HAD BEEN INJECTED WITH RADIESSE IN THE EAR LOBES AND DISTAL NOSE AREA. PATIENT DEVELOPED SEVERE SWELLING WITH PUSTULES PRESENT FROM THE RIGHT NASAL CREASE UP TO HIS GLABELLA, 1 DAYS POST-INJECTION. PATIENT WENT TO THE HOSPITAL FOR TREATMENT AS THE CIPRO PRESCRIBED BY DR DID NOT HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1006711

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention