BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY FLOOR CUSHIONS (BEVELED GLOW)

    MDR report key: 3043353 · Received March 13, 2013

    Report

    Report Number
    2020362-2013-00122
    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 WHEN THE BEVELED CUSHION IS REMOVED THERE IS A SLIPPERY SUBSTANCE ON THE SURFACE ON THE FLOOR NOT VISIBLE TO THE EYE OR TOUCH. THIS WAS DISCOVERED DURING USE BUT THERE WAS NO INCIDENT OR INJURY REPORTED. MORE INFO 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 PT OR STAFF INCIDENTS OR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106439 POSEY FLOOR CUSHIONS (BEVELED GLOW) FNL J. T. POSEY CO. 6027R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK