BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOT

    MDR report key: 17662862 · Received August 31, 2023

    Report

    Report Number
    3014527682-2023-00010
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 31, 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 INVOLVED IN THIS EVENT IS PART OF A SURGICAL CONVENIENCE KIT ASSEMBLED BY ROI CPS, LLC AND IS NOT MANUFACTURERED BY ROI CPS, LLC.

    Description of Event or Problem · 0

    PAPER RULER IN THE MARKER, LABEL, RULER SET IS NOT WATERPROOF. THE RULER WAS PLACED INSIDE A TROCAR DURING THE PROCEDURE AND THE RULER IN THE SET LEFT PIECES INSIDE THE TROCAR. THE PIECES HAD TO BE RETRIEVED BY THE CLINICIAN. THE MARKER, LABEL, RULER SET IS INTENDED TO BE USED EXTERNALLY AND NOT INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514420 VISCOT MARKER, LABEL, RULER SET FTY VISCOT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown