BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1 NORMOTHERMIC IRRIGATING SYSTEM

    MDR report key: 20218 · Received March 2, 1995

    Report

    Report Number
    20218
    Event Type
    Injury
    Date Received
    March 2, 1995
    Date of Event
    November 29, 1994
    Report Date
    December 8, 1994
    Manufacturer
    LEVEL 1 TECHNOLOGIES INC.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WATER USED FOR BLADDER IRRIGATION EXTRAVASATED INTO PERITONEUM.THE FLUID WARMER WAS CONNECTED VIA ROLLER PUMP TO THE FOLEY CATHETER. THE RETURN LINE WAS CONNECTED TO THE SUPRAPUBLIC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 NORMOTHERMIC IRRIGATING SYSTEM FLUID WARMER LEVEL 1 TECHNOLOGIES INC. H600

    Patients

    Seq Age Sex Outcome Treatment
    1 80 * Hospitalization| L| R