BEUDAMED
    FDA Adverse Event Other Summary report: N

    BASIC X-TRA TRACTION SHOE COVER, UNIVERSAL

    MDR report key: 488672 · Received October 9, 2003

    Report

    Report Number
    3003880811-2003-00001
    Event Type
    Other
    Date Received
    October 9, 2003
    Date of Event
    September 10, 2003
    Report Date
    October 9, 2003
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE FELL WHILE WEARING DAMP SHOE COVERS AND BRUISED AND LACERATED THEIR JAW AND SUSTAINED A CHIPPED TOOTH. REPORTEDLY RECEIVED A HAIRLINE FRACTURE OF THE JAW. THE INDIVIDUAL WAS SEEN IN THE ER BY A DENTIST. NO HOSPITALIZATION WAS REQUIRED NOR WAS SURGERY REQUIRED. THE SHOE COVERS WERE DAMP FROM BEING IN A SURGERY ROOM WHERE THE FLOOR WAS WET. THE FLOOR HAD RECENTLY BEEN POLISHED AND WAS DRY WHERE THE FALL OCCURRED. KIMBERLY-CLARK CORP HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFORMATION RECEIVED FROM OUTSIDE SOURCE PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC X-TRA TRACTION SHOE COVER, UNIVERSAL SHOE COVER FXP KIMBERLY-CLARK CORP. NA 20403FW13:01

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention