BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3409249 · Received October 4, 2013

    Report

    Report Number
    2135225-2013-00094
    Event Type
    Other
    Date Received
    October 4, 2013
    Date of Event
    August 28, 2013
    Report Date
    September 11, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP DR (B)(6) REPORTED SEEING HER AGAIN ONE WEEK LATER AND HER SWELLING WAS MUCH IMPROVED. SHE STATED SHE HAS SEEN THE PT SEVERAL TIMES SINCE AND SOME REDNESS REMAINS; HOWEVER, HER SWELLING HAS RESOLVED. DR (B)(6) REPORTED SHE IS STILL CONCERNED ABOUT THE REDNESS BUT NOW FEELS IT IS DUE TO AN AREA OF SMALL BROKEN BLOOD VESSELS. SHE INTENDS TO HAVE THE PT FOLLOW-UP WITH HER IN ONE MONTH AND WILL GIVER HER A LASER TREATMENT TO REDUCE ANY REMAINING REDNESS. THE DEVICE HISTORY RECORD FOR RADIESSE LOT 1033801 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

    DR (B)(6) REPORTED THE PT WAS INJECTED ON (B)(6) 2013 IN THE LEFT NASOLABIAL FOLD WITH RADIESSE. A 1.5CC SYRINGE WAS USED AFTER BEING MIXED WITH 0.2CC OF 2 PERCENT LIDOCAINE. THIS WAS THE PT'S THIRD RADIESSE PROCEDURE. THE PROCEDURE WAS PERFORMED WITHOUT INCIDENT ALTHOUGH SHE DID DEVELOP A LARGE AREA OF REDNESS AND BRUISING. DR (B)(6) WAS SCHEDULED TO GO OUT OF TOWN FOR SEVERAL DAYS SO SHE PRESCRIBED ANTIBIOTIC, KEFLEX FOR THE PT AS A PRECAUTION. THE PT LATER BEGAN TO HAVE INCREASED SWELLING AND SHE DECIDED TO GO TO URGENT CARE AS DR (B)(6) WAS UNAVAILABLE. THE URGENT CARE PHYSICIAN CHANGED HER ANTIBIOTIC TO CLINDAMYCIN. THE PT STILL DID NOT SEE ANY IMPROVEMENT IN HER SYMPTOMS WITH THE REDNESS AND SWELLING STILL BEING SIGNIFICANT SO SHE WENT TO THE EMERGENCY ROOM THE FOLLOWING DAY. SHE WAS TREATED WITH IV ANTIBIOTICS AND A CAT SCAN WAS PERFORMED AT THE EMERGENCY ROOM. THEY INSTRUCTED HER TO ADD BACTRIM TO HER TREATMENT REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504156 RADIESSE DERMAL FILLER INEJCTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 1033801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIESSE MIXED WITH 0.2CC OF 2 PERCENT LIDOCAINE