BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3802998 · Received May 1, 2014

    Report

    Report Number
    2135225-2014-00024
    Event Type
    Other
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L CATALOG # 8071M0H1, ADD'L LOT NUMBERS: 100069535, 10071716. ADD'L EXPIRATION DATE: 08/2015, 01/2016. ADD'L MFR DATES: 09/2013, 01/2014. DURING F/U ON (B)(6) 2014 (B)(6), MEDICAL ASSISTANT REPORTED THE PT IS NOW DOING WELL WITH THE SYMPTOMS RESOLVED. TREATMENT MODALITIES WERE NOT PROVIDED. THE DEVICE HISTORY RECORD FOR RADIESSE LOTS #100060347, 100069535 AND 100071716 WERE REVIEWED. ALL REQUIRED TESTING SPECS FOR THESE LOTS WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MERZ CUSTOMER, (B)(6), NP AT THE (B)(4) OF MEDICINE-(B)(4) CONTACTED MERZ REGARDING A PT INJECTED WITH RADIESSE DERMAL FILLER ON (B)(6) 2014 BY CLINIC COORDINATOR, (B)(6), LPN. THE PT WAS INJECTED WITH FIVE (1.5 CC) SYRINGES FOR (B)(6) FACIAL LIPOATROPHY. ON (B)(6)2014, THE RIGHT CHEEK AREA BECAME RED AND SORE; HOWEVER, THE PT DID NOT REPORT HIS SYMPTOMS UNTIL (B)(6) 2014. HE RETURNED TO THE CLINIC ON (B)(6) 2014 WITH AN AREA 2-3 CM IN DIAMETER THAT WAS SCABBED OVER AND BLACKISH IN COLOR. THE SURROUNDING TISSUE WAS RED AND INFLAMED. MERZ MANAGER CLINICAL AESTHETIC SERVICES, (B)(6), RN, BSN CONSULTED WITH (B)(6) WHO IS NOW MANAGING THE PT'S CARE. THEY DISCUSSED POSSIBLE TREATMENT OPTIONS USED BY OTHER HCPS SUCH AS KEEPING THE AREA CLEAN, VINEGAR SOAKS, AND THE USE OF OCCLUSIVE DRESSINGS SUCH AS AQUAPHOR. HYPERBARIC OXYGEN TREATMENT MAY BE USED IN SEVERE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261861 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100060347

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 0.6 CC OF 1% LIDOCAINE PLUS EPI