BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE VOICE

    MDR report key: 2126483 · Received June 10, 2011

    Report

    Report Number
    2135225-2011-00054
    Event Type
    Other
    Date Received
    June 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MERZ AESTHETICS (FORMERLY BIOFORM MEDICAL)
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT IDENTIFIERS WERE PROVIDED. THE VOCAL FOLD AUGMENTATION WAS PERFORMED BY DR. (B)(6). THE AMOUNT OF RADIESSE VOICE, INJECTION DATE, THE DATE OF SURGICAL REMOVAL AND THE RADIESSE VOICE LOT USED WERE NOT PROVIDED IN THIS ARTICLE. THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE PT OUTCOME AFTER THE CAHA WAS REMOVED, WAS NOT PROVIDED IN THE ARTICLE. THE AUTHOR (PHYSICIAN INJECTOR) INDICATES THAT THE CAHA DISTRIBUTED TO THE INFRAGLOTTIC SUBMUCOSA WAS TECHNICAL IN NATURE AND NOT A SPECIFIC COMPLICATION OF RADIESSE VOICE.

    Description of Event or Problem · 1

    THIS ADVERSE EVENT WAS REPORTED IN THE JOURNAL: LONG-TERM RESULTS OF CAHA FOR VOCAL FOLD AUGMENTATION, THE LARYNGOSCOPE 121: 313-319, FEBRUARY 2011. NINETY PTS (ALL OVER THE AGE OF 18 YRS) WHO HAD BEEN TREATED WITH A TOTAL OF 108 VOCAL FOLD INJECTIONS WITH RADIESSE VOICE INJECTIONS WERE EVALUATED. THREE PTS EXPERIENCED ADVERSE EVENTS, REQUIRING SURGICAL REMOVAL OF THE CAHA. THE PT WAS INJECTED WITH RADIESSE VOICE FOR VOCAL FOLD AUGMENTATION. DURING THE RADIESSE VOICE INJECTION, IT WAS NOTED THAT THE PT HAD AN INFRAGLOTTIC COLLECTION OF CAHA, DUE TO INADVERTENT PLACEMENT DURING AN IN OFFICE TRANSORAL INJECTION. ALTHOUGH NOT LIFE-THREATENING, THE CAHA REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE VOICE INJECTABLE IMPLANT KHJ MERZ AESTHETICS (FORMERLY BIOFORM MEDICAL) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention