BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3142277 · Received May 24, 2013

    Report

    Report Number
    2135225-2013-00051
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED THE PT RESPONDED WELL TO THE ANTIBIOTICS AND DIAGNOSED THE PT'S SYMPTOMS AS A SKIN INFECTION. DURING FOLLOW-UP THE MEDICAL ASSISTANT REPORTED THE PT HAS HEALED NICELY WITH NO FURTHER ISSUES REPORTED. THE DEVICE HISTORY RECORD FOR RADIESSE LOT 100063249 WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED INJECTING A PT WITH 1.5CC OF RADIESSE DERMAL FILLER IN THE MARIONETTE LINES ON (B)(6) 2013. TWO DAYS POST-INJECTION, THE PT RETURNED TO THE OFFICE PRESENTING WITH PUSTULES, REDNESS AND SWELLING AND AN AREA THAT APPEARED TO BE ABRADED. THE PT REPORTED SELF-TREATING WITH H2O2 AND BACITRACIN AND STATED THE PUSTULES HAD WHITE, PUS-LIKE DRAINAGE AND WOULD BLEED IF RUBBED. THE PT WAS PRESCRIBED DOXYCYLINE AND THE H2O2 AND BACITRACIN WAS DISCONTINUED. SHE RETURNED TO THE OFFICE ON (B)(6) 2013 WITH THE ABRASION AND PUSTULES WHICH WERE DRY AND THE ABSENCE OF ERYTHEMA. THE SKIN WAS HEALING NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230554 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 100063249

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention MIXED WITH 0.5CC OF 2% LIDOCAINE