BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1946232 · Received December 27, 2010

    Report

    Report Number
    2135225-2010-00094
    Event Type
    Other
    Date Received
    December 27, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 8, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1020108 WERE REVIEWED; ALL REQUESTED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THESE LOTS.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS CALLED IN BY A NURSE INJECTOR. DURING A ROUTINE FOLLOW UP ON THE PT STATUS POST RADIESSE INJECTION, THE PT STATED SHE HAD FEVER AND A RASH ON THE BACK, HEAD AND NECK; AND HIGH FEVER (39 DEG. C) AND WAS SHAKING, A WEEK POST RADIESSE INJECTION. NO INFECTION, RASH, REDNESS OR OOZING IN THE LOCAL AREA INJECTED. THE PT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH CELLULITIS. INTRAVENOUS ANTIBIOTIC, NAME AND DOSE UNK, WAS PROVIDED DURING HER OVERNIGHT STAY AT THE HOSPITAL; SHE WAS RELEASED TO HOME THE NEXT DAY WITH ORAL ANTIBIOTIC, NAME, DOSE AND FREQUENCY UNK. ON (B)(6) 2010, MEDICAL AFFAIRS CONSULT, (B)(6), PA SPOKE WITH THE INJECTING NURSE, THE PT DID NOT THINK THE INFECTION WAS RADIESSE RELATED. UNABLE TO DETERMINE WITH CERTAINTY WHAT THE CAUSATIVE AGENT OF PT'S CELLULITIS WAS. ON (B)(6) 2010, DURING PT STATUS/RECOVERY FOLLOW-UP, THE INJECTING NURSE STATED THE PT IS "FINE" AS INFORMED BY PT VIA PHONE. NO FURTHER FOLLOW-UP WILL BE DONE BY THE FACILITY.

    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.) 1020108

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R