BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER SCANNER

    MDR report key: 21832275 · Received April 14, 2025

    Report

    Report Number
    21832275
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 10, 2025
    Manufacturer
    MEDA CO., LTD
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MULTIPLE PATIENTS WERE BLADDER SCANNED AND THE READINGS WERE INACCURATE RESULTING IN PATIENTS HAVING ANOTHER PROCEDURE SUCH AS STRAIGHT CATHED. PRIOR TO THIS ISSUE, THE PROBE WAS REPLACED. THE DEVICE IS ONLY 3 YEARS OLD. DEVICE MANUFACTURER- LABORIE MEDICAL TECHNOLOGIES, DEVICE MODEL MD-600.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269025 BLADDER SCANNER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO MEDA CO., LTD MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male