BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2132185 · Received June 7, 2011

    Report

    Report Number
    2135225-2011-00047
    Event Type
    Other
    Date Received
    June 7, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MERZ AESTHETIC, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED INJECTING A PT WITH RADIESSE WITHOUT DIFFICULTY. THE NEXT MORNING, ON (B)(6) 2011, THE PT REPORTED SWELLING ON HER CHEEKS, MALAR AREA, LIPS, NECK, AND LOWER EYE LIDS. DR. (B)(6) INSTRUCTED THE PT TO GO TO THE EMERGENCY ROOM (ER). WHEN HE FOLLOWED-UP WITH THE ER STAFF, HE WAS TOLD THAT THE PT COMPLAINED OF CHEST PAIN. ALL TESTS PERFORMED ON PT WERE NEGATIVE FOR MYOCARDIAL INFARCT. FOR HER SWELLING, AN ER ALLERGIST GAVE THE PT BENADRYL AND STEROIDS, ROUTE AND DOSES WERE UNK. HER BREATHING WAS OK. SHE WAS ADMITTED TO THE HOSP FOR OBSERVATION DUE TO HER CHEST PAIN. DR. (B)(6) DID NOT THINK THAT HER CHEST PAIN WAS RELATED TO RADIESSE. ON (B)(6) 2011, DR. (B)(6) PROVIDED ADD'L INFO. THE CHEST PAIN RESOLVED, THE PT WAS RELEASED TO HOME ON (B)(6) 2011. DR. (B)(6) HAD SEEN THE PT ON (B)(6) 2011, AND SHE HAD NOTICEABLY REDUCED SWELLING AT THE INJECTION SITES, AND NO CHEST PAIN. THE PT "LEFT TOWN FOR (B)(4) FOR (B)(4)"; AND IS NOT EXPECTED TO BE SEEN BY DR. (B)(6). DR. (B)(6) STATED AGAIN THAT HE DID NOT BELIEVE THE EVENT OF CHEST PAIN WAS RELATED TO THE RADIESSE INJECTION. ON (B)(6) 2011, DURING CONSULTATION WITH DR. (B)(6) REGARDING HIS PT, HE INDICATED THIS WAS PT'S SECOND RADIESSE TREATMENT. FIRST TIME WAS A MID-FACE AUGMENTATION WITH TYPICAL SWELLING WHICH RESOLVED. MOST RECENT TREATMENT WAS TO THE NASOLABIAL FOLDS AND MARIONETTE LINES. WITHIN 24 HOURS, SHE DEVELOPED GLOBAL FACIAL SWELLING AND EDEMA THAT EXTENDED INTO HER NECK. NO RESPIRATORY COMPROMISE. SHE WAS SENT TO THE ER WHICH SHE WAS ADMITTED FOR COMPLAINTS OF CHEST PAIN AND WORKUP WAS FOUND TO BE UNREMARKABLE. SHE WAS SEEN BY AN IMMUNOLOGIST AND REPORTEDLY WAS TOLD THIS WAS AN ALLERGIC REACTION TO THE PRODUCT. SHE IS NOW ON PREDNISONE AND IS DOING MUCH BETTER. PER DR. (B)(6), HE DID NOT THINK THAT PT'S CHEST PAIN WAS RELATED TO RADIESSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETIC, INC. 1024872

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization RADIESSE WAS MIXED WITH 0.2 CC OF 1% LIDOCAINE| PRIOR TO INJECTION.