BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK VOICE

    MDR report key: 11181182 · Received January 15, 2021

    Report

    Report Number
    3013417188-2020-00008
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 18, 2020
    Report Date
    December 21, 2020
    Manufacturer
    SOFREGEN MEDICAL, INC.
    Product Code
    MIX
    PMA / PMN Number
    K180631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INJECTION PROCEDURE INFORMATION WAS PROVIDED TO SOFREGEN MEDICAL AS PART OF A COLLECTION/REVIEW OF A POST-MARKET SITE INITIATED CLINICAL STUDY. THE REVIEW OF THE PERTINENT SILK VOICE DEVICE MANUFACTURING RECORDS CONFIRMS THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. PRODUCT LABELING AND RISK MANAGEMENT CONTAIN APPROPRIATE INFORMATION REGARDING EDEMA OF THE LARYNX (SWELLING OF THROAT) AND AIRWAY OBSTRUCTION. VIDEO REVIEW OF THE PROCEDURE SUGGESTED THAT THE INJECTION OF SILK VOICE WAS CONSIDERED ROUTINE WITHOUT OVERCORRECTION. THE PHYSICIAN DID NOT FEEL THE EVENT WAS RELATED TO THE PATIENT'S UNDERLYING DISEASES AND CONCOMITANT MEDICATION. THE PHYSICIAN REPORTED THE PRESENCE OF IPSILATERAL LARYNGEAL EDEMA AT THREE DAYS POST INJECTION AUGMENTATION AND TREATED THE PATIENT WITH HIGH DOSE CORTICOSTEROIDS. THE PATIENT RESPONDED RAPIDLY TO TREATMENT WITH IMPROVED BREATHING, IMPROVED SWALLOWING, AND DIMINISHED DISCOMFORT. FOLLOW-UP LARYNGOSCOPY DEMONSTRATED SIGNIFICANT IMPROVEMENT IN LEFT LARYNGEAL SWELLING. THIS REPORTED COMPLICATION WAS REVIEWED BY THE STUDY'S CLINICIAN COMMITTEE AND WAS PERCEIVED TO BE COMPARABLE TO THE RARE IDIOSYNCRATIC REACTIONS REPORTED FROM PRODUCTS CONTAINING HYALURONIC ACID.

    Description of Event or Problem · 1

    THIS INJECTION PROCEDURE INFORMATION WAS PROVIDED TO THE MANUFACTURER AS PART OF A COLLECTION/REVIEW OF A POST-MARKET SITE INITIATED CLINICAL STUDY. A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH A 24 MONTH HISTORY OF LEFT VOCAL FOLD PARALYSIS RELATED TO METASTATIC LUNG CANCER. ON (B)(6) 2020, A CLINICAL EVALUATION CONFIRMED LEFT VOCAL FOLD PARALYSIS WITH GLOTTAL INSUFFICIENCY, VOICE LOSS, AND DYSPHAGIA WITH RISK OF ASPIRATION. ON (B)(6) 2020, INJECTION AUGMENTATION WAS PERFORMED WITH 0.6 CC SILK VOICE INTO THE LEFT VOCAL FOLD VIA A THYROHYOID PERCUTANEOUS APPROACH. VIDEO OF THE PROCEDURE WAS REVIEWED BY THE PHYSICIAN AND DESCRIBED AS ROUTINE WITHOUT OVERCORRECTION. ON (B)(6) 2020, VIA TELEMEDICINE, THE PATIENT REPORTED LEFT-SIDED THROAT DISCOMFORT AND MILD SWALLOWING DIFFICULTY. AFTER THE FOLLOW-UP, THE PATIENT DEVELOPED WORSENING SWALLOWING DIFFICULTY AND INCREASING DIFFICULTY WITH BREATHING. THE PATIENT CALLED THE CLINIC ON (B)(6) 2020 AND WAS ADMITTED FOR FURTHER EVALUATION. LARYNGEAL ENDOSCOPY DEMONSTRATED LEFT SUPRAGLOTTAL LARYNGEAL MUCOSAL SWELLING WITH REDUCED CALIBER OF AIRWAY. THE PATIENT WAS THEN TREATED WITH INTRAMUSCULAR FOLLOWED BY INTRAVENOUS STEROIDS, NEBULIZED RACEMIC EPINEPHRINE INHALATION, DIPHENHYDRAMINE, AND ICU ADMISSION FOR AIRWAY OBSERVATION. THE PATIENT RESPONDED RAPIDLY WITH IMPROVED BREATHING, IMPROVED SWALLOWING, AND DIMINISHED DISCOMFORT. FOLLOW UP LARYNGOSCOPY DEMONSTRATED SIGNIFICANT IMPROVEMENT IN LEFT LARYNGEAL SWELLING. THE PATIENT WAS DISCHARGED ON (B)(6) 2020 ON ORAL STEROIDS, AND A FOLLOW-UP APPOINTMENT ON (B)(6) 2020 CONFIRMED SIGNIFICANT IMPROVEMENT WITH A "VERY GOOD" VOICE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75879 SILK VOICE SILK VOICE MIX SOFREGEN MEDICAL, INC. 19-0105

    Patients

    Seq Age Sex Outcome Treatment
    1