BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOECOVER/ANTISKID/FLUIDREST/UNI

    MDR report key: 2406727 · Received January 10, 2012

    Report

    Report Number
    1423537-2012-00001
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    December 15, 2011
    Report Date
    January 10, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY THE CUSTOMER COULD NOT PROVIDE THE LOT NUMBER, AND THE SAMPLE WAS DISCARDED IN THE ER. WITHOUT THE LOT NUMBER, WE ARE NOT ABLE TO REVIEW THE DEVICE HISTORY RECORD TO IDENTIFY IF THERE WAS ANY EXCEPTION DURING THE MANUFACTURE OF THESE SHOE COVERS. WITHOUT THE SAMPLE, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. HISTORICAL TRENDING OF THIS PRODUCT CODE WAS DONE, AND NO TREND WAS IDENTIFIED. PRODUCTION PERSONNEL WERE MADE AWARE OF THIS COMPLAINT, AND WE WILL CONTINUE TO MONITOR FOR TRENDS. THE NURSE'S AGE WAS IDENTIFIED AS (B)(6).

    Description of Event or Problem · 1

    CIRCULATING RN SLIPPED AND FELL IN THE OR. APPARENTLY THERE WAS NOTHING ON THE FLOOR. SHE HIT HER HEAD, AND BRIEFLY LOST CONSCIOUSNESS. SHE WENT TO THE ER, AND A CAT SCAN AND HEAD X-RAYS WERE DONE. SHE HAD A CONCUSSION. SHE RETURNED TO WORK ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOECOVER/ANTISKID/FLUIDREST/UNI SHOE COVER WITH ANTI SKID SOLE FXP CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other