BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIED MEDICAL STENT EXTRAFLOW STENT

    MDR report key: 963785 · Received December 11, 2007

    Report

    Report Number
    MW5004653
    Event Type
    Injury
    Date Received
    December 11, 2007
    Date of Event
    December 6, 2007
    Report Date
    December 11, 2007
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT PLACED IN LEFT URETER IN 2007. DURING REMOVAL TWO MONTHS LATER, THE STENT BROKE IN 2 PLACES. RETAINED STENT HAD TO BE SURGICALLY REMOVED. DATES OF USE THREE MONTHS IN 2007. 62 DAYS. DIAGNOSIS OR REASON FOR USE: POST LASER LITHOTRYPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLIED MEDICAL STENT EXTRAFLOW STENT URETERAL STENT FAD APPLIED MEDICAL 6FX28CM 1036687

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability