BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL

    MDR report key: 501913 · Received December 5, 2003

    Report

    Report Number
    MW1030486
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Date of Event
    November 24, 2003
    Report Date
    December 5, 2003
    Manufacturer
    DAVOL, INC.
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPTING TO REMOVE BATTERIES FROM HOUSING UNIT, REPORTER FOUND THE BATTERIES LEAKING AND STILL WARM TO THE TOUCH. THE UNIT HAD BEEN TURNED OFF AT THE END OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL LAPAROSCOPIC IRRIGATOR KQT DAVOL, INC. 0026870 41FNN019

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other