BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVER, SHOE, OPERATING-ROOM

    MDR report key: 11761724 · Received May 3, 2021

    Report

    Report Number
    11761724
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    October 1, 2020
    Report Date
    October 13, 2020
    Manufacturer
    TANCHEUNG JULI PLASTICS, CO.
    Product Code
    FXP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NUMEROUS REPORTS OF BOOTIES BEING VERY SLIPPERY, CAUSING MULTIPLE STAFF TO SLIP. ADDITIONALLY, BECAUSE OF THE THIN AND EASILY TORN MATERIAL, THE SHOE COVERS PROVIDE INADEQUATE PROTECTION FOR BLOOD AND OTHER SPILLS. STAFF HAVE HAD TO DISCARD THEIR SHOES DUE TO BLOOD EASILY PERMEATING THE SHOE COVER MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661758 COVER, SHOE, OPERATING-ROOM FXP TANCHEUNG JULI PLASTICS, CO.

    Patients

    Seq Age Sex Outcome Treatment
    1