BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 19679555 · Received July 5, 2024

    Report

    Report Number
    19679555
    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

    DURING TOTAL JOINT PREP IT WAS NOTED THAT THERE WAS LINT BEING LEFT ON THE STERILE LEG AFTER USING IT TO BLOT DRY PREPPING SOLUTION. THE LEG WAS RE-PREP USING DIFFERENT TOWELS. MD MADE AWARE AND ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474035 MEDICHOICE DRAPE, SURGICAL KKX OWENS & MINOR DISTRIBUTION, INC. ORT04B 2308GD09B

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male