BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC

    MDR report key: 1010527 · Received February 11, 2008

    Report

    Report Number
    1010527
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 7, 2008
    Manufacturer
    RUSCH, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD URINARY RETENTION, SO A FOLEY URINARY CATHETER WAS PLACED, AND THE BALLOON INFLATED WITHOUT DIFFICULTY. BLOOD WAS NOTED. THE CATHETER WAS DISCONTINUED AND UROLOGY CONSULTED. EXAMINATION REVEALED A URETHRA RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC CATHETER, URINARY KOD RUSCH, INC. * *
    2 * KIT, INSERTION KOD C.R. BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention