BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEVELED FLOOR CUSHION

    MDR report key: 3043355 · Received March 13, 2013

    Report

    Report Number
    2020362-2013-00123
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED TO BE RETURNED, BUT HAS NOT BEEN RECEIVED.(B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE MAT IS MOVED FROM THE LOCATION IT HAS BEEN RESTING ON THE FLOOR, THERE IS A SLIPPERY SUBSTANCE THAT IS NOT VISIBLE. CUSTOMER REPORTED YOU CAN NOT SEE OR FEEL IT, BUT STEPPING ONTO THE LOCATION IS LIKE WALKING ON ICE. MORE INFORMATION RECEIVED IS THAT THE STAFF IS STILL HAVING ISSUES WITH THE FLOOR BEING SLIPPERY WHERE THE MATS HAVE BEEN EVEN AFTER THE CLEANING SOLUTION WAS CHANGED. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO INCIDENTS OR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106208 BEVELED FLOOR CUSHION FNL J. T. POSEY CO. 6026 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK