BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK, INC

    MDR report key: 261170 · Received February 3, 2000

    Report

    Report Number
    MW1018064
    Event Type
    Malfunction
    Date Received
    February 3, 2000
    Date of Event
    January 13, 2000
    Report Date
    February 2, 2000
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DECLOTTING PROCEDURE, MICROWIRE TIP BROKE OFF IN SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK, INC MICROWIRE TIP- INTRODUCER SET DYB COOK, INC. COOK MP1S-501 948172

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other