BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA FIRM URETERAL STENT

    MDR report key: 10436674 · Received August 20, 2020

    Report

    Report Number
    MW5096178
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 19, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT WAS ATTEMPTED TO BE PLACED IN PATIENT THEN BROKE. HAD TEAR ON THE DISTAL END. REMOVED IN ONE PIECE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899548 UNIVERSA FIRM URETERAL STENT STENT, URETERAL FAD COOK MEDICAL LLC UFH-500-R 13203016

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR