BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8314518 · Received February 7, 2019

    Report

    Report Number
    8314518
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 11, 2019
    Report Date
    January 23, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    UDI-DI
    00191072029041
    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 ASSURANCE ISSUE: FOUND A HAIR IN A STERILE PACK. NOTICED PRIOR TO PATIENT ENTERING ROOM. PACK AND ALL SUPPLIES REMOVED. NO DETRIMENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107765 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDAV04D 698181 00191072029041

    Patients

    Seq Age Sex Outcome Treatment
    1