BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1016804 · Received March 20, 2008

    Report

    Report Number
    2135225-2008-00018
    Event Type
    Injury
    Date Received
    March 20, 2008
    Date of Event
    January 21, 2007
    Report Date
    March 19, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS RECEIVED THROUGH A STATEMENT OF CLAIM THROUGH THE SUPERIOR COURT OF JUSTICE. THE PATIENT DID NOT FILE A REPORT WITH EITHER DISTRIBUTOR OF RADIESSE OR BIOFORM MEDICAL, INC (THE MANUFACTURER OF RADIESSE). THIS COMPLAINT IS BEING FILED DUE TO THE ALLEGED SERIOUSNESS OF THE COMPLAINT, AS DESCRIBED IN THE STATEMENT OF CLAIM. NO ADDITIONAL INFORMATION HAD BEEN PROVIDED BY THE PATIENT, PHYSICIAN/CLINIC, OR ATTORNEYS. ON 1/14/08, BIOFORM MEDICAL WAS DISMISSED FROM THESE CLAIMS. RADIESSE IS NOT APPROVED FOR USE IN THE LIPS. THE LOT NUMBERS FOR RADIESSE DERMAL FILLER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MEDICAL DEVICE REPORT DECISION TREES WERE COMPLETED FOR FDA, WHEN THE COMPLAINT WAS FIRST RECEIVED; IT WAS NOT THOUGHT AT THE TIME THE INFECTION WAS SERIOUS ENOUGH TO FILE AN MDR. IN DOING A SECOND REVIEW OF THE COMPLAINT AND MDR DECISION TREES, AN MDR WILL BE FILED WITH THE FDA DUE TO THE SERIOUSNESS OF THE INFECTION (REQUIRED AN ORAL AND INTRAVENOUS ANTIBIOTIC).

    Description of Event or Problem · 1

    THE FOLLOWING REPORT HAD BEEN SUBMITTED TO BIOFORM MEDICAL, INC VIA A STATEMENT OF CLAIM FROM A LAW FIRM. THE PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER THE LIPS FOR LIP ENLARGEMENT. THE PATIENT REPORTED SEVERE SWELLING TWO DAYS AFTER THE INJECTION. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND AN ANESTHETIC FOR THE LIPS. SIX DAYS FOLLOWING THE INJECTION, THE PATIENT WAS PUT ON AN INTRAVENOUS ANTIBIOTICS (NOT HOSPITALIZED). ALSO REPORTED IN THE CLAIM, BUT NOT CONFIRMED, IS THAT THE PATIENT WOULD REQUIRE CORRECTIVE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention