BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVOCATH

    MDR report key: 13633463 · Received March 1, 2022

    Report

    Report Number
    13633463
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 22, 2022
    Report Date
    February 25, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PROXIMAL BALLOON WOULD NOT INFLATE DURING PROCEDURE. NO ADVERSE HARM TO PATIENT. NEW CATHETER UTILIZED W/O ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390923 RENOVOCATH CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN RENOVORX, INC. MMRC120-DB-1111 Z2458918G

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Male