BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 386294 · Received April 2, 2002

    Report

    Report Number
    386294
    Event Type
    Malfunction
    Date Received
    April 2, 2002
    Date of Event
    March 25, 2002
    Report Date
    March 28, 2002
    Manufacturer
    KENDALL COMPANY
    Product Code
    NAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING A STERILE PACKAGE OF 4X4 KENDALL CURITY GAUZE SPONGES, A FOREIGN SUBSTANCE WAS FOUND ON GAUZE INSIDE PACKAGE. (2) 12 PLY, 4X4 GAUZE SPONGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE KENDALL CURITY GAUZE SPONGES NAB KENDALL COMPANY * 20396801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other