BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2900276 · Received December 27, 2012

    Report

    Report Number
    2135225-2012-00153
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    August 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT CALLED MERZ AESTHETICS ON (B)(6) 2012 TO REPORT SWELLING THAT STARTED ON (B)(6) 2012 IN BOTH CHEEKS. SHE STATED HER CHEEKS ARE REALLY SWOLLEN. SHE TOOK BENADRYL. THE PT WAS INJECTED WITH RADIESSE (LOT 1032344) ON (B)(6) 2012. THE INJECTOR WAS (B)(6), GENERAL SURGEON. THE PT HAS RECEIVED FIVE PRIOR INJECTIONS OF RADIESSE IN 2012 WITH NO ADVERSE EVENT. ON (B)(6) 2012, THE PT STATED THAT SHE HAD GONE INTO THE HOSPITAL FOR TESTS (FOR 3 DAYS). SHE COULD NOT REMEMBER THE DATES, BUT STATED THAT IT WAS 3-4 DAYS AFTER SHE HAD CALLED MERZ AESTHETICS. THE RADIESSE WAS RULED OUT (PER THE PT). THE BLOOD WORK WAS POSITIVE FOR (B)(6). THE PT HAD BEEN IN AN AREA OF (B)(6) THAT HAD VALLEY FEVER. THE DOCTORS THOUGHT HER ILLNESS MIGHT BE RELATED TO BEING IN THAT AREA IN (B)(6). ALSO, WAS HAVING A TOOTH CAPPED AROUND THAT TIME. THE DOCTORS SAID IT LOOKS LIKE SHE HAD AN INFECTION IN HER LEFT CHEEK, POSSIBLY FROM A TOOTH INFECTION. THE PT STATED THAT SHE HAD SCARRING ON HER LUNGS. WHEN THE PT WAS IN THE HOSPITAL, SHE HAD AN MRI, CT SCANS, AND NO DETERMINATION TO ROOT CAUSE WAS MADE. SHE STATED THAT SHE STARTED GETTING BETTER ABOUT ONE WEEK AFTER SHE WAS RELEASED FROM THE HOSPITAL. SHE STATED THAT THE SWELLING HAD STARTED IN (B)(6) (PREVIOUSLY, SHE HAD STATED THAT THE SWELLING STARTED ON (B)(6) 2012). THE PT STATES THAT CURRENTLY SHE IS FINE (THE SWELLING HAS RESOLVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER IMJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1032344

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization LIDOCAINE