BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLARYN PLUS INJECTABLE IMPLANT

    MDR report key: 12173035 · Received July 15, 2021

    Report

    Report Number
    12173035
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 12, 2021
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    MIX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS UNABLE TO BE DELIVERED TO THE PATIENT IN THE SYRINGE PROVIDED WITH THE INJECTION. IT NEVER FLOWED THROUGH THE INJECTION DEVICE IN THE BOX THAT THE INJECTION IMPLANT CAME IN. THE PROLARYN PLUS ON THE LONG NEEDLE WAS PLACED 5 MM DEEP INTO THE LEFT TVC, JUST ANTERIOR TO THE VOCAL PROCESS IN THE LATERAL ASPECT OF THE TVC. THIS WAS EXTREMELY DIFFICULT TO INJECT D/T THE VISCOSITY. AFTER MULTIPLE ATTEMPTS ONLY ABOUT 0.1 ML WAS ABLE TO INJECTED AND IT PLUGGED MULTIPLE NEEDLES. THE PROLARYN GEL WAS THEN USED AND ABOUT 0.3 ML OF THIS WAS INJECTED INTO THE SAME SPOT, BULKING THE CORD TOWARDS MIDLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069623 PROLARYN PLUS INJECTABLE IMPLANT SYSTEM, VOCAL CORD MEDIALIZATION MIX MERZ NORTH AMERICA, INC. 8044M0K5 100132455

    Patients

    Seq Age Sex Outcome Treatment
    1 32120 DA