BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE VOICE

    MDR report key: 1300429 · Received January 30, 2009

    Report

    Report Number
    2135225-2009-00008
    Event Type
    Injury
    Date Received
    January 30, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND IN A PROFESSIONAL JOURNAL; FIVE PATIENTS WITH GLOTTAL INSUFFICIENCY WHO WERE INJECTED WITH RADIESSE VOICE (CAHA) EXPERIENCED A SUBOPTIMAL INJECTION. ALL PATIENTS UNDERWENT ENDOSCOPIC REVISION SURGERY UNDER GENERAL ANESTHESIA. NO COMPLICATIONS OCCURRED DURING EXCISION. THREE PATIENTS REQUIRED NO FURTHER LARYNGEAL INTERVENTIONS FOR VOICE QUALITY. TWO PATIENTS WHO HAD PERSISTENT GLOTTAL INSUFFICIENCY WITH A DECLINE IN VOCAL QUALITY UNDERWENT A SUBSEQUENT TYPE I THYROPLASTY WITH EXCELLENT RESULTS. TWO PATIENTS IN WHICH PATHOLOGICAL ANALYSIS WAS AVAILABLE, A LOCAL FOREIGN BODY REACTION WAS NOTED WITHOUT THE PRESENCE OF EXPANSIBLE GRANULOMAS. ALL PATIENTS EXPERIENCE SUBJECTIVE AND OBJECTIVE IMPROVEMENTS. SUPERFICIAL INJECTION INTO THE SUBEPITHELIAL SPACE IS A RARE COMPLICATION OR INJECTION LARYNGOPLASTY WITH CAHA. PLACEMENT IN THIS AREA WILL HAVE DELETERIOUS VOICE RAMIFICATIONS. EXCESSIVE INJECTION OF THIS DURABLE COMPOUND MAY LEAD TO OVER-MEDIALIZATION THAT MAY NOT SPONTANEOUSLY RESOLVE BY RESORPTION. COMPLETE CONTROL, OFTEN WITH GENERAL ANESTHESIA, DURING INITIAL INJECTION MAY DECREASE THE INCIDENCE OF THESE COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS FOUND IN A PROFESSIONAL JOURNAL; PATIENTS WITH GLOTTAL INSUFFICIENCY, WHO WERE INJECTED WITH RADIESSE VOICE (CAHA) EXPERIENCED A SUBOPTIMAL INJECTION. LARYNGOSCOPE, 118:2260-2263, 2008

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE VOICE INJECTABLE IMPLANT LMH BIOFORM MEDICAL 8044M0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention