BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVOCATH

    MDR report key: 14235645 · Received April 28, 2022

    Report

    Report Number
    14235645
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 19, 2022
    Report Date
    April 20, 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

    PRIOR TO INSERTION OF BALLOON, CATHETER SHEARED OFF BECOMING UNUSABLE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196913 RENOVOCATH CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN RENOVORX, INC. MMRC120-DB-1111 Z2459460B

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Male