BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHOE COVER, SMS, NONSKID, REG SZ

    MDR report key: 1297466 · Received January 9, 2009

    Report

    Report Number
    1417592-2009-00003
    Event Type
    Other
    Date Received
    January 9, 2009
    Date of Event
    December 8, 2008
    Report Date
    January 8, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STAFF MEMBER IN THE OR WAS TAKING INSTRUMENTS INTO THE DECONTAMINATION AREA. SHE FELL ON HER RIGHT SIDE AND INJURED HER THUMB, ELBOW, HIP AND ANKLE. A MRI WAS DONE AND NO FRACTURES WERE IDENTIFIED. SHE RETURNED TO WORK ON RESTRICTED DUTIES. THE DIRECTOR OF SURGERY IDENTIFIED A NUMBER OF FACTORS, WHICH MAY HAVE CONTRIBUTED TO THE INCIDENT. THERE WAS A SMALL AMOUNT OF WATER ON THE FLOOR. THE CAUTION STATEMENT ON THE PACKAGE STATES THAT HOSPITAL FLOORS ARE SOMETIMES WET AND THAT PERSONNEL WHO WEAR SHOE COVERS SHOULD BE AWARE THAT A RISK OF SLIPPING EXISTS AND THAT PRECAUTIONS SHOULD BE TAKEN. IN THE FUTURE, THE FACILITY WILL PLACE A LARGE MAT TO CATCH ANY DRIPPING FROM THE WET INSTRUMENTS. ANOTHER FACTOR WAS THE SHOES WORN BY THE END USER. THE FACILITY DID NOT FEEL THE HEEL WAS APPROPRIATE FOR USE WITH SHOE COVERS IN THE OR. THE LAST FACTOR RELATES TO THE FACT THAT THIS WAS NOT THE FIRST INJURY FOR THIS EMPLOYEE. THE FACILITY PLANS TO CONDUCT STAFF TRAINING CONCERNING SAFETY PROTOCOLS IN THE OR.

    Description of Event or Problem · 1

    REPORTEDLY, STAFF MEMBER FELL WHILE WEARING THE SHOE COVERS. A SMALL AMOUNT OF WATER WAS ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOE COVER, SMS, NONSKID, REG SZ NONE FXP MEDLINE INDUSTRIES, INC. NON28858 83963325-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention