BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHOE COVER, SMS, NON-SKID, X-L S

    MDR report key: 863137 · Received June 4, 2007

    Report

    Report Number
    1417592-2007-00025
    Event Type
    Other
    Date Received
    June 4, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 31, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED AND SENT TO MFR FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS ARE RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY STATED, THERE WERE THREE SEPARATE OCCURRENCES RELATED TO THE USE OF THE SHOE COVERS IN A ONE WEEK PERIOD. TWO OF THE OCCURRENCES OCCURRED IN THE OR AND ONE IN THE NURSERY. THE COVERS WERE ALLEGED TO BE MISSING THE NON-SKID STRIPS AND THREE EMPLOYEES FELL WHEN WALKING IN THEM. NO SERIOUS INJURY OCCURRED AS THE RESULT OF THE FALLS AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOE COVER, SMS, NON-SKID, X-L S SHOE COVER, OPERATING ROOM BWP MEDLINE INDUSTRIES, INC. NON28859 4502862803 - 5CS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR