BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFIT SHOECOVER, ANTISKID

    MDR report key: 288350 · Received August 4, 2000

    Report

    Report Number
    1423507-2000-00201
    Event Type
    Injury
    Date Received
    August 4, 2000
    Date of Event
    May 1, 2000
    Report Date
    August 4, 2000
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT IN MAY 2000, A SURGICAL ASSISTANT SLIPPED AND FELL WHILE WEARING THE SHOE COVERS. THE SHOE COVERS WERE MOIST AND HAD BEEN WORN FOR ABOUT 1 1/2 HRS. WHILE TRANSFERRING A PT FROM THE OR TABLE TO A CART, THE EMPLOYEE FELL AND SUSTAINED BLUNT TRAUMA TO THE HEAD BY HITTING THE OR TABLE AND THEN THE FLOOR. THE EMPLOYEE WAS OFF WORK FOR ABOUT 6 WEEKS AND STILL HAS SOME MEMORY DEFICITS. THERE IS A HISTORY OF PREVIOUS CONCUSSION IN AN AUTO ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAFIT SHOECOVER, ANTISKID DURAFIT SHOECOVER, ANTISKID FXP ALLEGIANCE HEALTHCARE CORP. 4852 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention