BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT COVER

    MDR report key: 2992511 · Received February 19, 2013

    Report

    Report Number
    2992511
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BROADLINE MEDICAL, INC
    Product Code
    FXP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KNEE HIGH BOOTIE COVERS WERE USED IN THE LABOR AND DELIVERY ARE PERMEABLE. THE DOCTOR REMOVED THE COVERS TO DISCOVER THE SHOES WERE CONTAMINATED WITH FLUIDS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TO PROTECT THE STAFF'S SHOES AND CLOTHING FROM CONTAMINATION OF FLUIDS, ESPECIALLY BODILY FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72542 BOOT COVER SHOE COVER, KNEE HIGH FXP BROADLINE MEDICAL, INC B77-5032 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *