BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOT

    MDR report key: 17912793 · Received October 11, 2023

    Report

    Report Number
    3014527682-2023-00015
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 22, 2023
    Report Date
    October 11, 2023
    Manufacturer
    VISCOT MEDICAL LLC
    Product Code
    FTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RULER DISINTEGRATED IN THE PATIENT WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767776 VISCOT MARKER, LABEL, RULER SET FTY VISCOT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown