BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3027638 · Received March 22, 2013

    Report

    Report Number
    2135225-2013-00032
    Event Type
    Other
    Date Received
    March 22, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE REPORTED LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED ON (B)(6) 2013 WITH ONE 1.5CC SYRINGE OF RADIESSE IN THE CHEEKS. ON (B)(6) 2013 THE PATIENT HAD SWELLING, RED WELTS AND BURNING UP TO FOREHEAD. THE PATIENT WAS OUT OF TOWN. THE PATIENT WENT TO THE (B)(6) CLINIC, IT WAS THOUGHT TO BE AN INFECTION AND LEVAQUIN WAS PRESCRIBED. THE PATIENT FEELS THAT SHE GOT WORSE AND IS GOING BACK TO THE DOCTOR. (B)(6), INJECTING NURSE NEVER HAD THIS HAPPEN WITH THE PATIENT BEFORE. SHE IS WONDERING IF THIS EVENT TRIGGERED SHINGLES. (B)(6), NURSE INJECTOR SPOKE TO A MERZ AESTHETICS PHYSICIAN ASSISTANT ON (B)(6) 2013: (B)(6) DESCRIBED INJECTING 1.5 CC OF LIDO MIXED PRODUCT TO THE MALAR PROMINENCE IN A BOLUS FASHION AND A SMALL AMOUNT THE SUPERIOR NLF IN A LINEAR FASHION. NOTHING USUAL WAS NOTED AT TIME OF TREATMENT. THE PATIENT CALLED SIX DAYS POST INJECTION TO REPORT RASH, SWELLING, TENDERNESS AND WELTS AROUND HER RIGHT EYE AND FOREHEAD. SHE WAS SEEN AT (B)(6), THE AREA WAS CULTURED AND PLACED ON ANTIBIOTICS. SHE IS IMPROVING BUT WONDERS IF IT IS RELATED TO HER RADIESSE INJECTIONS. ON (B)(6) 2013 THE MERZ AESTHETICS PHYSICIAN ASSISTANT (PA) RECEIVED A PHOTO ALBUM OF PHOTOS FROM (B)(6). THE PHOTOS WERE REVIEWED AND A FOLLOW UP CALL WAS PLACED TO (B)(6) BY THE MERZ AESTHETICS PA. SHE SHARED WITH HER THAT SHE HAVE NEVER SEEN THIS TYPE OF REDNESS AND SWELLING BEING DIRECTLY RELATED TO A RADIESSE INJECTION. THIS IS NOT CONSISTENT WITH A VASCULAR EVENT AND IF ONE THOUGHT ABOUT AN ALLERGY; THE REDNESS EXTENDS WELL BEYOND WHERE THE PRODUCT WAS INJECTED AND WOULD MOST LIKELY BE BILATERAL. SHE HAS SOME SIGNIFICANT SWELLING TO THE MEDIAL CANTHUS WHICH SHE MIGHT CONSIDER TEAR DUCT OBSTRUCTION BUT WOULD NOT MAKE SENSE WHY THE REDNESS EXTENDS TO THE UPPER/LATERAL PORTION OF HER FOREHEAD. SHE WOULD NOT RULE OUT SHINGLES GIVEN THE HISTORY OF HER SYMPTOMS AND LOCATION OF THE RASH IN THE V1 DERMATOME. SHE MIGHT CONSIDER HAVING THE PATIENT FOLLOW UP WITH HER PRIMARY CARE MD SINCE SHE IS STILL EXPERIENCING BURNING, ITCHING AND TINGLING WHICH SEEMS (B)(6) IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119596 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 100060526

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention