BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA

    MDR report key: 3840265 · Received April 30, 2014

    Report

    Report Number
    3840265
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    May 21, 2013
    Report Date
    March 28, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING A PACKAGED UNIVERSA FIRM URETERAL STENT, THE STENT WAS CRACKED AT THE CURL. THIS WAS DISCOVERED PRIOR TO USE AND A SECOND URETERAL KIT WAS USED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258272 UNIVERSA STENT, URETERAL FAD COOK, INC. * U2329302

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR