BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE VOICE

    MDR report key: 2896517 · Received December 27, 2012

    Report

    Report Number
    2135225-2012-00099
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    September 1, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED TO MERZ AESTHETICS THAT PT WAS INJECTED WITH RADIESSE VOICE IN (B)(6) 2012, THEN DEVELOPED DIFFUSE, SEVERE ITCHINESS AND HIS WIFE NOTICED HIVES ON HIS CHEST. SHE IMMEDIATELY RETURNED HIM TO THE OFFICE. WHILE HE HAD NO RESPIRATORY NOISE, HIS VOICE HAD BECOME LOW-PITCHED AND ROUGH. EXAMINATION REVEALED MILD TACHYCARDIA WITH NORMAL BLOOD PRESSURE, DIFFUSE URTICARIA, AND MARKED FACIAL ERYTHEMA AND EDEMA. HIS EYELIDS HAD SWOLLEN SHUT. AN ALLERGY SPECIALIST WITHIN THE SAME DEPARTMENT WAS CONSULTED AND A DIAGNOSIS OF ANAPHYLAXIS WAS MADE. AFTER PLACING THE PT IN A RECUMBENT POSITION, 0.3 MILLIGRAMS OF EPINEPHRINE (1:1000) WAS GIVEN INTRAMUSCULARLY IN ADDITION TO SUPPLEMENTAL OXYGEN. HIS VITAL SIGNS REMAINED STABLE AND HIS URTICARIA STARTED TO IMPROVE. HE WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT WHERE HE REC'D INTRAVENOUS HYDRATION, DIPHENHYDRAMINE, DEXAMETHASONE, AND CONTINUED OBSERVATION FOR A LATE-PHASE REACTION. HIS SYMPTOMS RESOLVED AFTER SIX HRS AND HE WAS DISCHARGED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE VOICE INECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1032305

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization 1CC OF 1% LIDOCAINE W/ EPINEPHRINE 1:100,000| TOPICAL 2% LIDOCAINE| PHENYLEPHRINE