BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOT

    MDR report key: 17827150 · Received September 27, 2023

    Report

    Report Number
    3014527682-2023-00012
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 27, 2023
    Manufacturer
    VISCOT MEDICAL LLC
    Product Code
    FTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RULER FROM THE MARKER, LABEL, RULER SET INVOLVED IN THIS EVENT IS PART OF A SURGICAL CONVENIENCE KIT ASSEMBLED BY ROI CPS, LLC AND IS NOT MANUFACTURERD BY ROI CPS, LLC. THE MANUFACTUER, VISCOT, CONFIRMED THAT THE RULER INVOLVED IN THIS EVENT IS NOT INTENTED TO BE USED INTERNALLY. THE UNITENDED INTERNAL USE LED TO THE EVENT.

    Description of Event or Problem · 0

    THE RULER IN THE MARKER, LABEL, RULER SET IN PACK IS DISINTEGRATING WHEN GETTING WET OR BEING USED IN AN OPEN WOUND. THE ITEM WAS RETRIEVED IN PIECES FROM THE PATIENT AND REMOVED FROM THE STERILE FIELD. THE MARKER, LABEL, RULER SET IS INTENDED TO BE USED EXTERNALLY AND NOT INTERNALLY AS DESCRIBED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984048 VISCOT MARKER, LABEL, RULER SET FTY VISCOT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other