BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 LAPAROTOMY SPONGES - PRE WASHED

    MDR report key: 2223917 · Received August 15, 2011

    Report

    Report Number
    2223917
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 15, 2011
    Manufacturer
    AMD RITMED
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SURGICAL TEAM OPENED A PACKAGE OF FIVE LAP SPONGES AND THE SCRUB PERSON FOUND A HAIR IN THE MIDDLE OF THE SPONGES. ITEMS REMOVED FROM THE AREA AND THE SCRUB PERSON CHANGED THEIR GLOVES. THE STERILE TABLE WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 LAPAROTOMY SPONGES - PRE WASHED SPONGES, GAUZE GDY AMD RITMED 1535 8447

    Patients

    Seq Age Sex Outcome Treatment
    1 *