BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK VOICE INJECTABLE IMPLANT

    MDR report key: 16145445 · Received January 12, 2023

    Report

    Report Number
    16145445
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 6, 2023
    Report Date
    January 6, 2023
    Manufacturer
    SOFREGEN MEDICAL INC.
    Product Code
    MIX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SOFREGEN (SILK VOICE) IMPLANT WAS FOUND TO BE UNSTERILE ONCE THE OUTER BOX WAS OPENED. IT APPEARED THAT THE PACKAGE WAS NOT COMPLETELY SEALED BY THE MANUFACTURER MAKING IT UNSTERILE. IMPLANT WAS NOT USED AND REMOVED FROM THE ROOM - NEVER TOUCHED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535372 SILK VOICE INJECTABLE IMPLANT SYSTEM, VOCAL CORD MEDIALIZATION MIX SOFREGEN MEDICAL INC. SV-3001 22-0369

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA Female