BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2912942 · Received December 21, 2012

    Report

    Report Number
    2135225-2012-00152
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS INJECTED WITH 1.5 CC OF RADIESSE ON (B)(6) 2012 IN THE POSTERIOR JAWLINE, LEFT SIDE OF PRE-JOWL SULCUS, BOTH CHEEKS. THE PT SAID THAT SHE HAS REACTED FROM LIDOCAINE BEFORE. AFTER INJECTION STARTED SHE COMPLAINED OF ITCHINESS TO THE LEFT CHEEK POST INJECTION WHICH SUBSIDED. THE INJECTION CONTINUED WITH NO COMPLAINTS FROM THE PT. THE PT'S INJECTED SITES PRESENTED NO ERYTHEMA, MILD EDEMA, NO COMPLAINTS OF PAIN OR DISCOMFORT. PT CONTINUED TO HAVE XEOMIN BOTULINUM INJECTIONS TO THE UPPER FACE ONLY (NOWHERE NEAR THE INJECTED SITES WITH RADIESSE) AND ESTHELIS BASIC TO THE LIPS AND UPPER LIP RHYTIDES. PT TOLERATED ALL TREATMENTS WELL AND HAD NO COMPLAINTS. PT WAS IN CLINIC FOR APPROX 2 HOURS AND PRESENTED NO COMPLICATIONS. SHE TOOK REACTINE POST INJECTIONS. THE PT DROVE HOME TO THE US AND ONLY THEN STARTED TO SEE INCREASING EDEMA A FEW HOURS POST INJECTIONS. APPROX 1 HOUR LATER SWELLING SET IN. THE PHYSICIAN WAS NOTIFIED AND THE PT WAS TOLD TO APPLY ICE TO THE INJECTED SITES. THE PHYSICIAN WAS CALLED AGAIN 10 MINUTES LATER BY THE PT AS THE EDEMA CONTINUED TO INCREASE. BECAUSE THE SWELLING CONTINUALLY BECAME WORSE THE PHYSICIAN TOLD THE PT TO GO TO THE HOSPITAL. THE PT WENT TO THE EMERGENCY ROOM AND WAS GIVEN ORAL MEDS AND AN IV WAS STARTED. THE PT FOLLOWED UP WITH THE PHYSICIAN AFTER A FEW HOURS TO UPDATE HER PROGRESS AND WAS STABLE AND RESPONDING WELL TO TREATMENT GIVEN AT THE HOSPITAL. A COMPANY REP FROM MERZ (B)(4) SPOKE TO THE PT ON (B)(4) 2012, THE PT IS DOING MUCH BETTER. SHE SAID SHE'S JUST SWOLLEN AROUND HER NECK RIGHT NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization XEOMIN| ESTHELIS BASIC| 0.2CC 2% XYLOCAINE, EXP DATE 01/2015, LOT#99339071