BEUDAMED
    FDA Adverse Event Summary report: N

    SOLUTION WARMER

    MDR report key: 4302705 · Received October 31, 2014

    Report

    Report Number
    4302705
    Date Received
    October 31, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 31, 2014
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    LGZ
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    LAP SPONGES WERE PLACED IN A BAGGIE IN A WARMER SALINE BATH PER MD DIRECTIVE. AFTER USE IN THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD DEVELOPED A SMALL BLISTER. THE DEVICE WAS SET AT 110 DEGREES PRIOR TO USE. THE DEVICE WAS SEQUESTERED AND TESTS PERFORMED. THE DEVICE WAS SHOWN TO BE OUT OF CALIBRATION BY APPROXIMATELY 10 DEGREES AND THERE WAS A DISPLAY MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700318 SOLUTION WARMER WARMER, FLUID LGZ O.R. SOLUTIONS, INC. ORS-2066R *

    Patients

    Seq Age Sex Outcome Treatment
    1 *