BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP CHOLE PACK

    MDR report key: 574691 · Received February 11, 2005

    Report

    Report Number
    MW1034650
    Event Type
    Malfunction
    Date Received
    February 11, 2005
    Date of Event
    February 3, 2004
    Report Date
    February 11, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FNY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PARTICLES OF DIRT OR ?? FOUND INSIDE 7 QUART BLUE RING BASINS PART OF LAP CHOLE PACK. TWO SEPARATE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP CHOLE PACK 7 QUART BLUE RING BASIN FNY CARDINAL HEALTH 910726 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other