BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY CLEAN AND CARE TRAY

    MDR report key: 2711103 · Received August 17, 2012

    Report

    Report Number
    MW5026585
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 17, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OGV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BEING CARED FOR AT A HOME. WHEN TRACHEOSTOMY CARE KIT WAS OPENED BY FAMILY MEMBER, BLACK MATTER WAS NOTED ON A GAUZE DRESSING IN THE KIT. THE HOME CARE NURSE SUBSEQUENTLY OPENED ANOTHER KIT FROM THE SAME LOT NUMBER, AND IT ALSO CONTAINED A GAUZE WITH BLACK MATTER ON IT. NEITHER DRESSING WAS USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHEOSTOMY CLEAN AND CARE TRAY NONE OGV MEDLINE INDUSTRIES, INC. 12CY0032

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR