BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER SCANNER

    MDR report key: 20256029 · Received September 19, 2024

    Report

    Report Number
    20256029
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 12, 2024
    Manufacturer
    MEDA CO., LTD
    Product Code
    IYO
    UDI-DI
    06948941160008
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME INTO THE DEPARTMENT COMPLAINING OF URINARY RETENTION. BLADDER SCAN WAS ORDERED AND PERFORMED HOWEVER THE BLADDER SCANNER WAS NOT READING ACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746389 BLADDER SCANNER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO MEDA CO., LTD MD-6000 06948941160008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown