BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOT

    MDR report key: 17830351 · Received September 27, 2023

    Report

    Report Number
    3014527682-2023-00013
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 14, 2023
    Report Date
    September 27, 2023
    Manufacturer
    VISCOT MEDICAL LLC
    Product Code
    FTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MARKER, LABEL, RULER SET IN THIS EVENT IS PART OF A SURGICAL CONVENIENCE KIT ASSEMBLED BY ROI CPS, LLC AND IS NOT MANUFACTURERD BY ROI CPS, LLC.

    Description of Event or Problem · 0

    THE RULERS IN THE MARKER, LABEL, RULER SET ARE PATPER AND THE PHYSICIANS COMPLAIN THAT THEY START TO BREAK DOWN WHEN MEASURING WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272341 VISCOT MARKER, LABEL, RULER SET FTY VISCOT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown