BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 19679554 · Received July 5, 2024

    Report

    Report Number
    19679554
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    February 27, 2024
    Report Date
    February 27, 2024
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN USING MEDICHOICE OPERATION ROOM TOWEL TO BLOT LEG DRY AFTER APPLYING THE STERILE PREP, BLUE LINT NOTED ON PATIENT'S LEG AFTER REMOVING TOWEL. LEG PREPPED AGAIN, AND LINT THAT WAS VISIBLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474034 MEDICHOICE DRAPE, SURGICAL KKX OWENS & MINOR DISTRIBUTION, INC. ORT04B 2308GD09B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown