BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK VOICE

    MDR report key: 12453492 · Received September 10, 2021

    Report

    Report Number
    3013417188-2021-00008
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 12, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT UNDERWENT A VOCAL FOLD AUGMENTATION PROCEDURE IN WHICH SILK VOICE WAS IMPLANTED TO TREAT VOCAL FOLD PARALYSIS. SIX DAYS AFTER THE INJECTION, THE SUBJECT PRESENTED WITH DIFFICULTY BREATHING AT A HOSPITAL OTHER THAN THE TREATING HOSPITAL. HE WAS ADMITTED WITH HEMI-LARYNGEAL SWELLING AND TREATED WITH STEROIDS AND RACEMIC EPINEPHRINE. THE PATIENT RESPONDED TO THE TREATMENT AND WAS DISCHARGED THE NEXT DAY. LARYNGEAL EDEMA AND AIRWAY OBSTRUCTION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THIS PROCEDURE. PRODUCT LABELING AND RISK MANAGEMENT CONTAIN APPROPRIATE INFORMATION REGARDING EDEMA OF THE LARYNX AND AIRWAY OBSTRUCTION. 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. SIX DAYS AFTER THE INJECTION, THE SUBJECT PRESENTED WITH DIFFICULTY BREATHING AT A HOSPITAL OTHER THAN THE TREATING HOSPITAL. HE WAS ADMITTED WITH HEMI-LARYNGEAL SWELLING AND TREATED WITH STEROIDS AND RACEMIC EPINEPHRINE. THE PATIENT RESPONDED TO THE TREATMENT AND WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349739 SILK VOICE SILK VOICE MIX SOFREGEN MEDICAL, INC. 19-0107

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L IMMUNE THERAPY