BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1667036 · Received April 21, 2010

    Report

    Report Number
    2135225-2010-00015
    Event Type
    Injury
    Date Received
    April 21, 2010
    Date of Event
    December 24, 2009
    Report Date
    March 23, 2010
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS NOT REPORTED TO BIOFORM MEDICAL, INC, AT WHICH TIME, THE SYMPTOMS HAD ALREADY RESOLVED. THE PT, ALSO A PHYSICIAN, IS NOT A CURRENT RADIESSE CUSTOMER AND HAD SELF-TREATED HER SYMPTOMS. DURING A FOLLOW-UP WITH THE RADIESSE INJECTING PHYSICIAN, DR (B) (6) FELT THAT THE PT HAD AN UNDERLYING VIRAL INFECTION, THAT WAS AGGRAVATED BY THE RADIESSE DERMAL FILLER INJECTION. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1016215 WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE OF THE LOT. THERE WERE NO ABNORMALITIES NOTED;THERE ARE NO OTHER ADVERSE EVENTS REPORTED FOR THIS DEVICE LOT.

    Description of Event or Problem · 1

    A PT (PHYSICIAN) WAS INJECTED WITH RADIESSE DERMAL FILLER FOR THE THIRD TIME ON (B) (6) 2009, IN THE NASO LABIAL FOLDS. ONE DAY POST INJECTION, THE PT DEVELOPED UPPER LIP EDEMA AND BRUISING; PT SELF-TREATED WITH MEDROL DOSE PAK. THE PT DEVELOPED PUSTULE FORMATION, LESIONS AND REDNESS TO THE UPPER LIP MUCOSA; PT SELF-TREATED WITH BACTROBAN. THE PT RETURNED TO THE RADIESSE INJECTING PHYSICIAN ON (B) (6) 2009 AND HAD GREATLY IMPROVED. THE PT INDICATED THAT SHE HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER TWO PREVIOUS TIMES, BY AN UNIDENTIFIED PHYSICIAN. THERE WERE NO ISSUES AFTER THE FIRST INJECTION ((B) (6) OR (B) (6) 2008). THE PT EXPERIENCED AN ALLERGIC REACTION, TREATED WITH ANTIHISTAMINE, FOLLOWING THE SECOND RADIESSE INJECTION ((B) (6) OR (B) (6) 2009). THIS ADVERSE EVENT WAS REPORTED TO BIOFORM MEDICAL, INC. BY THE PT ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1016215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other