BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2424889 · Received January 12, 2012

    Report

    Report Number
    2135225-2012-00006
    Event Type
    Other
    Date Received
    January 12, 2012
    Date of Event
    March 18, 2011
    Report Date
    January 4, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE INFO: CAT#: 8069M0K1, LOT#: 1022316, EXPIR DATE: 08/2012. DEVICE MANUFACTURE DATE: 08/2010. MERZ AESTHETICS RECEIVED THIS REPORT ON 1/4/2012. THIS SYRINGE LOT, 1022436, WAS LISTED IN THE RECALL LETTER FROM AUGUST 2011 FOR POTENTIAL OF RADIESSE 1.5 CC SYRINGES LEAKING DURING USE. MERZ HAD NOT BEEN NOTIFIED OF THIS EVENT WHEN IT OCCURRED IN (B)(6) 2011. DR. (B)(6) DID NOT NOTICE ANY MEDIA LEAKING FROM THE PLUNGER DURING INJECTION. HE DID INDICATE THE PLUNGER SEEMED TO PUSH BACKWARD OUT OF THE SYRINGE. THE DEVICE HISTORY RECORDS FOR BOTH RADIESSE LOTS, 1022436 AND 1022316 WERE REVIEWED. THE REVIEW OF RADIESSE LOT 1022436 IS LISTED ABOVE. ALL REQUIRED TESTING SPECIFICATIONS FOR LOT 1022316 WERE MET PRIOR TO RELEASE, THERE WERE NOT ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED WITH RADIESSE DERMAL FILLER ON (B)(6) 2011, IN THE NL FOLDS, BY DR. (B)(6). THE PT DEVELOPED AN INFECTION ON THE LEFT SIDE A FEW DAYS LATER; THE PT WAS IN (B)(6) AND HAD SPOKEN WITH (B)(6), OVER THE PHONE. A PRESCRIPTION WAS PHONED-IN FOR THE PT FOR ORAL ANTIBIOTICS, BUT DID NOT HELP RESOLVE THE INFECTION. THE PT WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2011, AND THERE WAS TREATED WITH KEFLEX, DOXYCYCLINE, BACTRIM, ERTAPENEM, AND VANCOMYCIN. SHE WAS RELEASED FROM THE HOSPITAL AFTER 48 HOURS MONITORING. THE PT WAS BETTER AT THE TIME OF RELEASE AND HAS NOT HAD ANY RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1022436

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization