BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL KIT (HEMM 221238 SHEET THREE QUARTER REINFORCED 53X77)

    MDR report key: 7211764 · Received January 23, 2018

    Report

    Report Number
    7211764
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM (OR) STAFF BEGAN SETTING UP FOR SURGICAL PROCEDURE. AS THE SCRUB PERSON OPENED A 3/4 SHEET DRAPE (PART OF THE VASCULAR BYPASS TOTE), STAFF DISCOVERED A LARGE BEETLE, A FLY, AND HAIR ON THE INSIDE OF THE DRAPE UPON OPENING. DRAPE WAS REMOVED FROM OPERATING ROOM. THE STAFF IN THE ROOM BROKE DOWN THEIR SET UP AND OPENED A NEW TOTE. PATIENT WAS NOT AFFECTED AS PATIENT WAS NOT YET IN OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57079 SURGICAL KIT (HEMM 221238 SHEET THREE QUARTER REINFORCED 53X77) GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES INC. DYNJP2416

    Patients

    Seq Age Sex Outcome Treatment
    1