BEUDAMED
    FDA Adverse Event Other Summary report: N

    @SHOE COVER, SMS, NON-SKIN,X-L S

    MDR report key: 1351562 · Received March 23, 2009

    Report

    Report Number
    1417592-2009-00022
    Event Type
    Other
    Date Received
    March 23, 2009
    Date of Event
    February 18, 2009
    Report Date
    March 17, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A STAFF MEMBER FELL WHILE WEARING THE NON-SKID SHOE COVERS. THERE WAS NO WATER ON THE FLOOR. SHE APPARENTLY WENT TO SIT DOWN ON A STOOL AND THE STOOL BEGAN ROLLING. SHE TRIED TO BRACE HERSELF AND HER FEET SLID. SHE FELL AND SUFFERED A CONTUSION TO HER BACK. SHE WAS EVALUATED IN THE EMERGENCY ROOM. SHE IS RECEIVING PHYSICAL THERAPY. NO SAMPLE WAS PROVIDED FOR EVAL. SAMPLES FROM STOCK AS WELL AS SAMPLES FROM OTHER VENDORS HAVE BEEN SENT TO A TESTING HOUSE TO HAVE THE SLIP MEASURED PER ASTM F 1677. AT THIS TIME, NO ROOT CAUSE HAS BEEN IDENTIFIED AND NO CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMPLOYEE WENT TO SIT ON A STOOL AND AS IT BEGAN TO ROLL AWAY, SHE SLIPPED AND FELL, INJURING HER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 @SHOE COVER, SMS, NON-SKIN,X-L S NONE BWP MEDLINE INDUSTRIES, INC. NON28859 84105972-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other