BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDERSCAN

    MDR report key: 2915223 · Received December 24, 2012

    Report

    Report Number
    2915223
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    December 18, 2012
    Report Date
    December 24, 2012
    Manufacturer
    VERATHON
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SCANNER DID NOT SCAN CORRECTLY. THE DEVICE SCANNED 393ML-508ML, BUT WHEN THE PATIENT WAS CATHETERIZED WE OBTAINED 950ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADDERSCAN CYSTOMETER, ELECTRICAL RECORDING ITX VERATHON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES