BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTIRES, INC.

    MDR report key: 76385 · Received March 10, 1997

    Report

    Report Number
    76385
    Event Type
    Malfunction
    Date Received
    March 10, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 10, 1997
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY IT WAS NOTICED THAT THE RADIOPAQUE STRIP FROM THE 4X4'S WAS FLAKING OFF IN THE WOUND. THE SURGEON AND FIRST ASST WERE ABLE TO REMOVE AS MANY OF THE PIECES AS THEY COULD SEE. X-RAYS WERE TAKEN WITH NO PARTICLES SHOWING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE INDUSTIRES, INC. GAUZE 4X4 16PLY XRAY 10/BANDED GDY MEDLINE INDUSTRIES, INC. * 6K2011

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other