BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES INC

    MDR report key: 5177784 · Received October 26, 2015

    Report

    Report Number
    5177784
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 2, 2015
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL MEDIUM SIZE BLACK HAIRS WERE FOUND ON BLUE TOWEL THAT CAME WITH STERILE SCRUB GOWN ON EXTERIOR OF PACKAGE. SCRUB TECH RESCRUBED AND NEW GOWN AND GLOVES THROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707736 MEDICAL ACTION INDUSTRIES INC GENERAL SURGERY TRAY LRO MEDICAL ACTION INDUSTRIES INC 1012954

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR