BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 4150505 · Received October 7, 2014

    Report

    Report Number
    1033422-2014-00027
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 8, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FXP
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS COMPLETED. THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR THE LOT NUMBER REPORTED INDICATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO MANUFACTURING REQUIREMENTS. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4). DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING THAT THE OPERATING ROOM TECHNICIAN SLIPPED AND BROKE HER ARM WHILE WEARING THE SHOE COVERS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 STATES THE OPERATING ROOM TECHNICIAN INITIALLY CHANGED THE SHOE COVERS AFTER A PREVIOUS ENDOSCOPY PROCEDURE. THE OPERATING ROOM TECHNICIAN WAS THEN SETTING-UP THE SURGICAL SUITE FOR THE NEXT PROCEDURE, A KNEE ARTHROSCOPY SURGERY. THE OPERATING ROOM TECHNICIAN STATES AFTER SHE CHANGED THE SHOE COVERS, SHE WENT INTO THE BREAK ROOM AND THEN WENT INTO THE PROCEDURE ROOM TO SET-UP FOR THE NEXT CASE. THE FLOOR OF PROCEDURE ROOM FLOOR WAS NOT WET BUT THE OPERATING ROOM TECHNICIAN IS UNSURE IF THE FLOOR WAS WET DURING HER WALK TO AND FROM THE BREAK ROOM. THE OPERATING ROOM TECHNICIAN WALKED INTO THE HALLWAY TO GATHER MORE ITEMS FOR THE PROCEDURE CASE AND THEN WALKED BACK INTO PROCEDURE ROOM. WHEN SHE RETURNED TO THE PROCEDURE ROOM, SHE SLIPPED, FELL, AND BROKE HER RIGHT ARM. THE OPERATING ROOM TECHNICIAN ESTIMATES SHE WORE THE SHOE COVERS APPROXIMATELY FIVE MINUTES PRIOR TO THE FALL. TREATMENT INCLUDED WEARING AN ARM CAST FOR 5 WEEKS, AND NO ADDITIONAL FOLLOW-UP TREATMENTS WERE REQUIRED FOLLOWING REMOVAL OF THE CAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629649 XTRA TRAC SHOEC, XLG SURGICAL APPAREL SHOE COVER FXP KIMBERLY-CLARK HEALTH CARE 69254 CA4128001

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention