BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TRA TRACTION* SHOE COVER XLG

    MDR report key: 898872 · Received August 21, 2007

    Report

    Report Number
    9615517-2007-00097
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    July 24, 2007
    Report Date
    August 21, 2007
    Manufacturer
    KUNSHAN AIEDA NON-WOVEN PRODUCTS CO. LTD.
    Product Code
    FXP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR POTENTIAL LOT NUMBERS WERE CITED BY THE USER FACILITY. THESE LOTS WERE MANUFACTURED FROM APRIL 2006 THOUGH FEBRUARY 2007. THE SHOE COVER IS COATED WITH A HOT MELT SKID RESISTANT COATING. THE CONTRACT MANUFACTURER HAS PERFORMED THE FOLLOWING ANALYSES ON VARIOUS COMPLAINT SAMPLES RELATED TO SKID-RESISTANT SHOE COVER PERFORMANCE: COEFFICIENT OF FRICTION; GLUE APPLICATION; AND TRACTION LOSS. THE MANUFACTURE SITE HAS REINFORCED MACHINE MAINTENANCE, ON-LINE OPERATOR AND QUALITY INSPECTORS FOLLOW THE CORRECT SHOE COVERS MANUFACTURING OPERATION, AND ATTENTION TO APPROPRIATE HOT MELT SHOE COATING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USER FACILITY THAT THERE WERE SEVERAL CALLS REGARDING FALLS ASSOCIATED WITH THE USE OF EXTRATRACTION SHOE COVERS PRODUCT. THERE WERE NO INJURY OR MEDICAL INTERVENTION. THE SITE EXPRESSED CONCERNED OF POTENTIAL LIABILITY ASSOCIATED WITH FUTURE INCIDENTS. EXAMPLE GIVEN WAS TRANSPORT OF THE TRANSPLANT PATIENT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED ABOVE BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-TRA TRACTION* SHOE COVER XLG SHOE COVER FXP KUNSHAN AIEDA NON-WOVEN PRODUCTS CO. LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR