BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADDER SCAN

    MDR report key: 12166260 · Received July 13, 2021

    Report

    Report Number
    MW5102521
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 10, 2021
    Manufacturer
    VERATHON INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I TOOK MY WIFE TO THE (B)(6) ER IN THE MORNING FOR SEVERE BACK PAIN. THE ER NURSE WAS TOLD BY THE ATTENDING DOCTOR TO DO A BLADDER SCAN. THE VERATHON BLADDER SCAN DEVICE REPEATEDLY FAILED TO FUNCTION. THE NURSE WAS NOT SURPRISED AS THIS HAPPENS FREQUENTLY AND USED AN OLDER DEVICE THEY KEEP AROUND DUE TO THIS SITUATION. I HAVE THE MN AND SN FOR THE FAULTY DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059575 BLADDER SCAN SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VERATHON INC. PD-020-0019

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention