BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL

    MDR report key: 500178 · Received December 9, 2003

    Report

    Report Number
    500178
    Event Type
    Malfunction
    Date Received
    December 9, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 2, 2003
    Manufacturer
    DAVOL INC
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HYDROSURG PLUS IRRIGATOR PRIMED BUT WOULD NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL HYDROSURGE PLUS LAP IRRIGATOR KQT DAVOL INC * 41FNN039

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other