BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX-LUBRISTENT

    MDR report key: 140844 · Received December 19, 1997

    Report

    Report Number
    140844
    Event Type
    Injury
    Date Received
    December 19, 1997
    Date of Event
    September 30, 1997
    Report Date
    October 3, 1997
    Manufacturer
    BARD UROLOGICAL DIV. C.R. BARD, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT C/O LT FLANK PAIN 9/29. BROWNISH URINE. THE STENT, UNABLE TO MAINTAIN THE PROXIMAL COIL, WAS MIGRATING DOWN THE LEFT URETER. A DIFFERENT MFR'S STENT WAS USED AS A REPLACEMENT. ORIGINAL LOT NUMBER OF DEFECTIVE STENT IS UNKNOWN. SAMPLE NOT AVAILABLE. MFR TO BE NOTIFIED BY MAT. MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX-LUBRISTENT Implant URETERAL STENT (DOUBLE PIGTAIL) FAD BARD UROLOGICAL DIV. C.R. BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| O| R