BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3131289 · Received May 20, 2013

    Report

    Report Number
    2135225-2013-00055
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 2013
    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

    THE DEVICE HISTORY RECORDS FOR THE REPORTED RADIESSE LOT WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED. PATIENT'S RECOVERY STATUS WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DR (B)(6) INJECTED A FEMALE PATIENT INTO CHEEK BONES, UNDER EYES, IN MARIONETTE LINES AND THE FRONT OF EARS WITH TWO RADIESSE SYRINGES. THE PATIENT ALSO HAD A FACIAL CHEMICAL PEEL. NO ISSUES WERE OBSERVED DURING THE PROCEDURES. AFTER THE INJECTION, PATIENT HAD MILD BRUISING AND SOME SWELLING IN THE NASOLABIAL FOLDS AND CHIN AREAS. ON (B)(6) 2013, THE PATIENT REPORTED SWELLING UNDER LEFT EYE WITH ITCHINESS. ON (B)(6) 2013, THE PATIENT REPORTED INCREASED SWELLING, HIVES, AND ITCHINESS IN THE SAME AREA. ON (B)(6) 2013, THE PATIENT ALSO HAD SOME REDNESS IN THE AREA AND WAS PRESCRIBED A CORTISONE CREAM. ON (B)(6) 2013, AS DR (B)(6) WAS OUT OF TOWN, THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM (ER); SHE HAD INCREASED SWELLING. DR (B)(6) RECEIVED A REPORT FROM THE ER. THE PATIENT WAS DIAGNOSED WITH CONTACT DERMATITIS AND CELLULITIS. SHE WAS GIVEN ORAL DURICEF (CEFADROXIL) - 500 MG X 7 DAYS, MEDROL DOSE PACK, ZERTEC, AND ATARAX - IM. ON (B)(6) 2013, THE PATIENT WAS SEEN BY DR (B)(6). THE SWELLING WAS PRESENT UNDER EYES, MORE PRONOUNCED UNDER LEFT EYE. PER PATIENT, SHE IS ABOUT 30-40% BETTER. DR (B)(6) IS ALSO CONSIDERING A DIAGNOSIS OF DELAYED ALLERGIC REACTION. ON (B)(6) 2013, DR (B)(6) SPOKE WITH (B)(4) AT MERZ ANESTHETICS. PER MEDICAL CONSULTATION, DR (B)(6) INJECTED TWO 1.5 CC SYRINGES IN VARIOUS AREAS OF THE FACE; NLF, ML AND CHEEKS WITH NO IMMEDIATE ISSUES. SEVEN DAYS POST INJECTION, PATIENT CALLED TO REPORT FACIAL ITCHING IN ALL OF THE INJECTED AREAS. PATIENT HAD NOT STARTED ANY NEW MEDICATIONS OR TOPICAL PRODUCTS. DR (B)(6) RECOMMENDED TOPICAL CORTISONE CREAM. TWO WEEKS POST TREATMENT THE PATIENT DEVELOPED A SEVERE SWELLING REACTION LOCALIZED TO ALL INJECTED AREAS. DR (B)(6) SENT HER TO THE EMERGENCY ROOM WHERE SHE WAS TREATED WITH MEDICATIONS. THE PATIENT IS DOING BETTER BUT THE SWELLING PERSISTS, DR (B)(6) IS CONCERNED ABOUT LONG TERM SWELLING. DR (B)(6) KNOWS THE CURRENT TREATMENT REGIMEN IS HELPING AND WILL CONTINUE TO MONITOR PATIENT CLOSELY. DR (B)(6) IS CERTAIN THIS REPRESENTS A SEVERE ALLERGIC REACTION. THEY DISCUSSED PATIENT'S PREVIOUS MEDICAL HISTORY AND THERE SEEMS TO BE NO OBVIOUS ALLERGY OR UNDERLYING IMMUNE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222998 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1030556

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention MULTI-VITAMINS| B12