BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8577286 · Received May 3, 2019

    Report

    Report Number
    8577286
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 17, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    UDI-DI
    00191072046109
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STERILITY ISSUE: DURING CASE SET UP THE STERILE EXTREMITY PACK WAS OPENED. THE CLEAR COVER WAS TORN OPEN AT WHICH POINT A HAIR WAS SEEN ON THE INSIDE OF THE CLEAR PACKAGE ON THE OUTSIDE OF THE BLUE TABLE COVER. PACK REMOVED FROM USE AND NEW PACK USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371064 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDEX31D 944191 00191072046109

    Patients

    Seq Age Sex Outcome Treatment
    1