BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOECOVER DURA FIT XL 200/PR

    MDR report key: 4277054 · Received November 25, 2014

    Report

    Report Number
    1423537-2014-00031
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 25, 2014
    Manufacturer
    CARDINAL HEALTH SINGAPORE 225 PTE LTD
    Product Code
    FXP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO EXCEPTION WAS RECORDED DURING PRODUCTION OF THIS LOT. THE DHR INDICATED THAT THE COEFFICIENT OF FRICTION WAS MEETING THE SPECIFICATION WHEN IT WAS FIRST PRODUCED, IT WAS NOTED THAT THE COF WAS FOUND TO DETERIORATE THROUGH TIME USUALLY IN STORAGE. THIS APPEARS TO BE AN INHERENT CHARACTERISTIC OF THE SHOE COVER. THE ROOT CAUSE FOR THE DETERIORATION CANNOT BE IDENTIFIED AT THIS TIME. CURRENTLY, THERE ARE NO DOCUMENTED CRITERIA FOR COEFFICIENT OF FRICTION. AS A RESULT, CARDINAL HEALTH HAS UTILIZED THE OSHA GUIDELINES FOR FLOOR CONDITIONS TO BE SLIP-RESISTANT AND HAVE A STATIC COEFFICIENT OF FRICTION (SCOF) VALUE OF 0.5 OR GREATER. CARDINAL HEALTH HAS AN INTERNAL COEFFICIENT FRICTION OF 0.68. HISTORICAL TRENDING WAS DONE AND THIS IS THE SECOND REPORT OF SLIPPERINESS IN THE PAST TWELVE MONTHS FOR THIS CATALOG NUMBER. THE COMPLAINT WAS FED BACK TO THE RELEVANT SECTION OF PRODUCTION FOR AWARENESS. A REFRESHER TRAINING SESSION WAS CONDUCTED FOR THE OPERATORS TO ENSURE THEY STRICTLY COMPLY WITH THE SPECIFICATION AND PRODUCTION METHODS. A CAPA PROJECT WAS RAISED TO ANALYZE THE CAUSE OF THE DETERIORATION AND THE ACTION NEEDED TO CONTAIN AND CORRECT THE ISSUE. AT THIS TIME, NO ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN, BUT WE WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS OF THIS ISSUE.

    Description of Event or Problem · 1

    WHILE WEARING THE SHOE COVERS, A NURSE SLIPPED AND CAUGHT HERSELF, BUT IN THE PROCESS WRENCHED/STRAINED HER BACK AND HAD PAIN FOR SEVERAL HOURS AFTERWARDS. SHE TOOK ADVIL AND APPLIED HEAT. SHE IS FINE NOW AND HAS NO COMPLAINTS AT THIS TIME. THE FLOOR HAD NOT BEEN RECENTLY WASHED/WAXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764592 SHOECOVER DURA FIT XL 200/PR COVER, SHOE, OPERATING-ROOM FXP CARDINAL HEALTH SINGAPORE 225 PTE LTD 14GEF182

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other