BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1949215 · Received December 29, 2010

    Report

    Report Number
    2135225-2010-00097
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1021069 WAS 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

    A MEDICAL ASSISTANT REPORTED THAT A PT HAD SWELLING AT LEFT NASOLABIAL (NL) FOLD AND LEFT MALAR AREA; AND PAIN WITH CHEWING FOOD AND DRINKING LIQUIDS POST RADIESSE INJECTION. THE PT WAS INJECTED INTO NL FOLDS AND ORAL COMMISSARS ON (B)(6) 2010, AND REPORTED SWELLING AND PAIN DURING A ROUTINE F/U CALL BY THE FACILITY. THE PT SELF TREATED WITH ORAL (B)(6), DOSE AND FREQUENCY WERE UNK. ON (B)(6) 2010, AN UPDATE WAS REC'D FROM THE PHYSICIAN'S OFFICE STATING THAT THE PT WAS SEEN IN THE OFFICE ON (B)(6) 2010, FOR FACIAL SWELLING AND REDNESS. THE PT WAS GIVEN ORAL ANTIBIOTICS FOR AN UNK DIAGNOSIS; NAME, FREQUENCY AND DOSE WERE UNK. IT WAS UNK IF THE ANTIBIOTIC TREATMENT WAS GIVEN TO TREAT A SPECIFIC INFECTION OR IT WAS GIVEN AS A PROPHYLACTIC. PER FACILITY CONTACT, THE PT DID NOT EXHIBIT FEVER, AND THERE WERE NO OPEN AREAS ON HER FACE. ON (B)(6) 2010, ADDITIONAL UPDATE WAS REC'D FROM THE PHYSICIAN'S OFFICE REGARDING THE PT STATUS UPDATE. THE PT WAS GIVEN A 10 DAY SUPPLY OF ORAL CEFALEXIN, DOSE AND FREQUENCY WERE UNK, FOR CELLULITIS AND FULLY RECOVERED.

    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.) 1021069

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention