BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDERSCAN

    MDR report key: 1645776 · Received March 11, 2010

    Report

    Report Number
    1645776
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 11, 2010
    Manufacturer
    VERATHON
    Product Code
    EXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE SIMPLY LOCKED UP AND WOULD NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADDERSCAN BLADDER SCANNER EXQ VERATHON BVI9400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR