BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOECOVER ANTI-SKID

    MDR report key: 8452503 · Received March 26, 2019

    Report

    Report Number
    1423537-2019-00295
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    December 28, 2018
    Report Date
    April 9, 2019
    Manufacturer
    LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD
    Product Code
    FXP
    UDI-DI
    20885380018357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. ACCORDING TO THE SUPPLIER THIS IS THE FIRST SLIPPERY ISSUE IN THE PAST 12 MONTHS. THE RAW MATERIALS USED ON THE PRODUCT ARE PROVIDED BY APPROVED SUPPLIERS, CONSISTENT TO THE BILL OF MATERIAL, PASSED INCOMING INSPECTION, AND THEY HAVE NOT CHANGED THEIR MANUFACTURING/STORING/TRANSFERRING PROCESSES ON THIS PRODUCT. FROM THE PROCESS REVIEW, THE SHOE COVER GLUE MACHINES ARE NORMAL, WITHIN CALIBRATION EXPIRATION DATE, AND ALL HAVE DAILY CHECKS, WEEKLY CHECKS AND MONTHLY MAINTENANCE. THE PRODUCTS ARE GLUED WITH VALIDATED PARAMETERS AND PRODUCED A IN NORMAL MANUFACTURING ENVIRONMENT. TESTS CONDUCTED DURING PRODUCTION SHOWED THE MEASURED COF (COEFFICIENT OF FRICTION) FACTOR TO BE MEETING THE SPECIFICATION. TWO PIECES OF SAMPLES WERE RETURNED FOR INVESTIGATION. THE ANTI-SLIP STRIPS ON SHOE COVERS ARE COMPLETE AND CLEARLY VISIBLE. THE WIDTH OF THE GLUE MEETS THE REQUIREMENT. THE SEWING LINE WAS LOCATED IN THE MIDDLE OF THE SOLE AND THE ANTI-SKID WAS EVENLY DISTRIBUTED ON BOTH SIDES. FROM THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE SUPPLIER WILL CONTINUE TO MONITOR THEIR MANUFACTURING PROCESS, INCLUDING MANUFACTURING ENVIRONMENT AND EQUIPMENT. THEY WILL MONITOR THE TREND FOR THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    A SAMPLE FOR EVALUATION HAS BEEN SHIPPED TO THE MANUFACTURER. THE EVALUATION IS STILL ONGOING. A FOLLOWUP MDR WILL BE FILED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    A STAFF MEMBER FELL AND WAS INJURED WHILE WEARING THE SHOE COVERS. THEY BELIEVE IT IS BECAUSE OF THE SHOE COVERS NOT HAVING ANY TREAD ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246802 SHOECOVER ANTI-SKID COVER, SHOE, OPERATING-ROOM FXP LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD 2854 18HDFNA046 20885380018357

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization