BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADDERSCAN PRIMEPLUS

    MDR report key: 11805743 · Received May 10, 2021

    Report

    Report Number
    MW5101270
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 6, 2021
    Manufacturer
    VERATHON INC.
    Product Code
    IYO
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    BLADDER SCANNER KEPT POPPING UP WITH "LOST CONNECTION" EVEN BEFORE CONTACT TO PATIENT CAN BE MADE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699595 BLADDERSCAN PRIMEPLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VERATHON INC. BLADDERSCAN PRIMEPLUS 121-0054683

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention