BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE MAJOR GENERAL PACK

    MDR report key: 9214591 · Received October 18, 2019

    Report

    Report Number
    MW5090510
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MEDLINE INDUSTIRES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLACK HAIR FOUND ON BLUE SPECIMEN CUP LID INSIDE MAJOR GENERAL PACK. PACK WAS REMOVED FROM THE ROOM AND A NEW ONE WAS OPENED. THE PT WAS NOT IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005856 MEDLINE MAJOR GENERAL PACK GENERAL SURGERY TRAY LRO MEDLINE INDUSTIRES, INC. 19GLA024

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR