BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE VOICE

    MDR report key: 3690791 · Received March 13, 2014

    Report

    Report Number
    2135225-2014-00017
    Event Type
    Other
    Date Received
    March 13, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MERZ NORTH AMERICA INC.
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LARYNGOSCOPE 123: 2237-2239, 2013. SEPTEMBER 2013 COHEN ET AL: SEVERE SYSTEMIC REACTION FROM CALCIUM HYDROXYLAPATITE VOCAL FOLD FILLER. JUSTIN C COHEN, MD, WILLIAM REISACHER, MD, MELANIE MALONE, MD, LUCIAN SULICA, MD.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH NO KNOWN FOOD OR AIRBORNE ALLERGIES UNDERWENT ESOPHAGOTOMY WITH MEDIASTINAL LYMPH NODE DISSECTION FOR SQUAMOUS CELL CARCINOMA. POST OPERATIVELY, HE COMPLAINED OF HOARSENESS, DECREASED VOCAL PROJECTION, COUGH, AND DYSPHAGIA AND WAS FOUND TO HAVE A LEFT VOCAL CORD PARESIS. SEVENTEEN DAYS AFTER SURGERY, HE UNDERWENT UNCOMPLICATED INJECTION AUGMENTATION IN THE OFFICE UNDER TOPICAL AND LOCAL ANESTHESIS, USING A TOTAL OF 0.5CC OF CARBOXYMETHYLCELLULOSE. ONE YEAR LATER, HIS PARESIS HAD PROGRESSED TO A FRANK PARALYSIS DUE TO RECURRENT CARCINOMA IN THE MEDIASTINUM. HIS VOICE WAS AGAIN BREATHY AND HIS COUGH HAD RETURNED. GIVEN HIS OVERALL PROGNOSIS, REPEAT INJECTION AUGMENTATION WITH A LONGER-LASTING MATERIAL WAS RECOMMENDED. PRIOR TO THE PROCEDURE, THE PATIENT TOOK 5MG OF ZOLPIDEM FOR RELAXATION. A 1CC OF 1% LIDOCAINE WITH EPINEPHRINE 1:100,000 WAS INJECTED SUBCUTANEOUSLY NEAR THE CRICOTHYROID SPACE. ADDITIONALLY, PLEDGETS WITH TOPICAL 2% LIDOCAINE AND PHENYLEPHRINE WERE PLACED IN THE NOSE. AFTER SEVERAL MINUTES, AUGMENTATION WAS PERFORMED PERCUTANEOUSLY UNDER FLEXIBLE LARYNGOSCOPIC CONTROL WITHOUT DIFFICULTY. A TOTAL OF 0.7CC PF CAHA WAS USED. HE TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED AFTER 20 MINUTES OF OBSERVATION. TEN MINUTES LATER, HE DEVELOPED DIFFUSE, SEVERE ITCHINESS AND HIS WIFE NOTICED HIVES ON HIS CHEST. SHE IMMEDIATELY RETURNED HIM TO THE OFFICE. HE DENIED RESPIRATORY DIFFICULTY BUT COMPLAINED OF A SUDDEN FEELING OF FATIGUE AND MALAISE. ADDITIONALLY, 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 IMMEDIATELY CONSULTED AND A DIAGNOSIS OF ANAPHYLAXIS WAS MADE. AFTER PLACING THE PATIENT IN A RECUMBENT POSITION, 0.3MG 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 RECEIVED INTRAVENOUS HYDRATION, DIPHENHYDRAMINE, DEXAMETHASONE AND CONTINUED OBSERVATION FOR LATE-PHASE REACTION. HIS SYMPTOMS RESOLVED AFTER 6 HOURS AND HE WAS DISCHARGED WITH NO FURTHER COMPLICATIONS. FOLLOW UP EXAMINATION 2 WEEKS LATER SHOWED NO SIGN OF RESIDUAL EDEMA WITH ADEQUATE AIRWAY. GLOTIC INSUFFICIENCY WAS WELL-ADDRESSED BY THE INJECTION. THE LOT NUMBER OF THE RADIESSE VOICE WAS NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150420 RADIESSE VOICE INJECTABLE IMPLANT KHJ MERZ NORTH AMERICA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention PHENYLEPHRINE IN THE NOSE| PLEGLETS WITH TOPICAL 2% LIDOCAINE AND| 1CC OF 1% LIDOCAINE WITH EPINEPHRINE 1:100,000 WAS| INJECTED SUBCUTANEOUSLY NEAR THE CRICOTHYROID| SPACE