BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 1301979 · Received January 30, 2009

    Report

    Report Number
    MW5009812
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    January 29, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING AT THE TIP OF THE CATHETER COLLAPSED OR BENT-DURING REMOVAL FORMING A RIDGE THAT CAUSED PAINFUL REMOVAL FOR PATIENT. REMOVED PER MD ORDERS BASED ON NORMAL PLAN OF CARE. REMOVED INTACT, RIDGE PRESENT MID TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER FOLEY CATHETER KOD BARD MEDICAL DIVISION REF # 1758SI18

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability