BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROFORCE

    MDR report key: 845496 · Received April 27, 2007

    Report

    Report Number
    845496
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 1, 2007
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BALLOON RUPTURED WHILE IN THE PT. DOCTOR TOOK X-RAYS TO CONFIRM AND PLACED A STENT IN THE LEFT URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROFORCE BALLOON DILATION CATHETER LIT BARD MEDICAL DIVISION * GFRA0168

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention