BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK VOICE

    MDR report key: 12526821 · Received September 24, 2021

    Report

    Report Number
    3013417188-2021-00010
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 8, 2021
    Manufacturer
    SOFREGEN MEDICAL, INC.
    Product Code
    MIX
    PMA / PMN Number
    K180631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT UNDERWENT A VOCAL FOLD AUGMENTATION PROCEDURE IN WHICH SILK VOICE WAS IMPLANTED TO TREAT VOCAL FOLD PARALYSIS. ONE DAY AFTER THE INJECTION, THE SUBJECT REPORTED DYSPHAGIA WITH RESULTANT GLOBUS AND PHLEGM SENSATION. THE SUBJECT WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH AUDIBLE INSPIRATORY AND EXPIRATORY STRIDOR WITH DEEP BREATHS. IPSILATERAL HEMILARYNGEAL WATERY EDEMA WAS OBSERVED ON FLEXIBLE LARYNGOSCOPY. THE PATIENT WAS TREATED WITH STEROID AND DISCHARGED 24 HOURS LATER WITH NO RESPIRATORY ISSUES AND TOLERATING HER DIET. LARYNGEAL EDEMA IS A KNOWN COMPLICATION ASSOCIATED WITH THIS PROCEDURE. PRODUCT LABELING AND RISK MANAGEMENT CONTAIN APPROPRIATE INFORMATION REGARDING EDEMA OF THE LARYNX. REVIEW OF THE PERTINENT SILK VOICE DEVICE MANUFACTURING RECORDS CONFIRMS THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A VOCAL FOLD AUGMENTATION PROCEDURE IN WHICH SILK VOICE WAS IMPLANTED TO TREAT VOCAL FOLD PARALYSIS. ONE DAY AFTER THE INJECTION, THE SUBJECT REPORTED DYSPHAGIA WITH RESULTANT GLOBUS AND PHLEGM SENSATION. THE SUBJECT WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH AUDIBLE INSPIRATORY AND EXPIRATORY STRIDOR WITH DEEP BREATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422518 SILK VOICE SILK VOICE MIX SOFREGEN MEDICAL, INC. 19-0107

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R ANASTAZOLE (LONG TERM)