BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULRICH POWER INJECTOR

    MDR report key: 10104976 · Received May 29, 2020

    Report

    Report Number
    MW5094761
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 25, 2020
    Report Date
    May 27, 2020
    Manufacturer
    ULRICH MEDICAL USA, INC.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMERGENCY ROOM CT ULRICH POWER INJECTOR 24HOUR INTERNAL PUMP TUBING RUPTURED/LEAKED, NO HARM TO PATIENT. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567313 ULRICH POWER INJECTOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ ULRICH MEDICAL USA, INC. M0190501

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other