BEUDAMED
    FDA Adverse Event Summary report: N

    CRANIOTOMY STERILE PACK LF

    MDR report key: 2151699 · Received June 24, 2011

    Report

    Report Number
    2151699
    Date Received
    June 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDLINE
    Product Code
    LRP
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    STERILE BUNDLES WERE OPENED. TECHNICIAN WENT TO OPEN A BAG WITHIN THE STERILE BUNDLE WHEN SHE NOTED A HAIR IN THE ITEMS ON THE FIELD. CONSEQUENTLY BOTH TABLES WERE TORN DOWN. REPLACEMENT SUPPLIES AND EQUIPMENT HAD TO BE ACQUIRED AND SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIOTOMY STERILE PACK LF TRAY, SURGICAL LRP MEDLINE DNYJ17478D 11BD0068

    Patients

    Seq Age Sex Outcome Treatment
    1 *