BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGE PREVALON TAP SYSTEM

    MDR report key: 8433441 · Received March 12, 2019

    Report

    Report Number
    8433441
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    December 19, 2018
    Report Date
    March 7, 2019
    Manufacturer
    SAG PRODUCTS LLC
    Product Code
    KME
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THROUGH THE PROCESS OF CONDUCTING AN INVESTIGATION RELATED TO AN ADVERSE EVENT, IT HAS BEEN NOTED THAT THE SAGE PREVALON TAP SYSTEM 2.0 IS NOT COMPATIBLE TO BE USED IN CONJUNCTION WITH THE STANDARD OPERATING ROOM WEDGE THAT IS OFTEN USED BY ANESTHESIA WHEN PTS ARE NOT ABLE TO TOLERATE LYING FLAT. WHEN THE MAT AND THE POSITIONING WEDGE ARE PLACED AGAINST EACH OTHER, THEY BECOME EXTREMELY SLIPPERY AND CAN LEAD TO PT FALLS IN THE OPERATING ROOM. CROSS-CHECK OF MFR RECOMMENDATIONS DO NOT ALERT USERS TO THIS POTENTIAL HAZARD AS THEY, SAGE MAY NOT BE AWARE. IT IS IMPORTANT TO NOTE THAT WHILE THIS PRODUCT WAS A CONTRIBUTING FACTOR TO THE EVENT IT WAS NOT THE DIRECT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208032 SAGE PREVALON TAP SYSTEM PREVALON TAP SYSTEM 2.0 KME SAG PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O