BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE VOICE

    MDR report key: 2896516 · Received December 27, 2012

    Report

    Report Number
    2135225-2012-00150
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, APPROX 30 MINS AFTER INJECTION OF RADIESSE VOICE, THE PT EXPERIENCED EDEMA OF THE LARYNX. SUBSEQUENTLY, A RE-INTERVENTION LARYNX WAS PERFORMED (LATERALIZATION LEFT VOCAL FOLD). FURTHER CORRECTIVE TREATMENT COMPRISED ADMINISTRATION OF CORTICOSTEROIDS. THE PT WAS INTUBATED FOR ONE DAY AND STAYED IN THE INTENSIVE CARE UNIT (ICU) FOR TWO DAYS. THE EVENT COMPLETELY RESOLVED AFTER 14 HRS AND THE PT WAS DISCHARGED HOME. IN THE OPINION OF THE REPORTING PHYSICIAN, THE EVENT WAS OF SEVERE INTENSITY. NO FURTHER INFO WAS PROVIDED. THE DEVICE HISTORY RECORDS FOR RADIESSE VOICE LOTS 1026166 AND 1032430 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR EACH OF THESE LOTS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED DURING THE MFG OF THESE LOTS. A SEARCH OF THE COMPLAINTS DATABASE REVEALED THAT THERE HAVE BEEN NO COMPLAINTS FOR EITHER LOT NUMBER. ADD'L LOT #: 1032430. ADD'L EXPIRATION DATE: 03/2014. ADD'L MANUFACTURE DATE: 03/2012.

    Description of Event or Problem · 1

    A REPORT FROM A (B)(6) PHYSICIAN WAS REC'D REGARDING A PT INJECTED WITH RADIESSE VOICE FOR AN UNK INDICATION ON AN UNK DATE. THE PT EXPERIENCED SEVERE OEDEMA OF THE VOCAL CORDS AND WAS TREATED FOR THE EVENT WITH CORTICOSTEROID INJECTIONS. THE PT SPENT A NIGHT IN THE INTENSIVE CARE UNIT. F/U REC'D (B)(6) 2012: THE REPORT CONCERNS (B)(6) MALE PT INJECTED WITH A TOTAL OF 1.4 ML OF RADIESSE VOICE IN THE AREA OF LARYNX LEFT AND RIGHT ON (B)(6) 2012. THE LEFT SIDE OF THE LARYNX WAS TREATED WITH 1 ML OF RADIESSE VOICE, THE RIGHT SIDE WAS TREATED WITH 0.4 ML. DEPTH OF INJECTION WAS REPORTED AS PARAGLOTTIC. EACH SIDE WAS INJECTED WITH TWO TO THREE INJECTION POINTS. GENERAL ANESTHESIA WAS PERFORMED PRIOR TO THE INJECTION. AT THE TIME OF REPORTING, IT WAS UNK WHETHER THE PT TOOK CONCOMITANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE VOICE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1026166

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization NONE PROVIDED