BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2861154 · Received November 27, 2012

    Report

    Report Number
    2861154
    Date Received
    November 27, 2012
    Date of Event
    July 25, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN OR STAFF WAS SETTING UP ROOM FOR REPAIR OF ANKLE FRACTURE, HAIR FOUND IN STERILE SET UP PACK. ROOM BROKEN DOWN AND SET UP AGAIN PRIOR TO PATIENT ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GENERAL SURGICAL TRAY LRO MEDLINE INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *