BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8300775 · Received February 4, 2019

    Report

    Report Number
    8300775
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 31, 2019
    Report Date
    January 31, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRP
    UDI-DI
    00191072029324
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HAIR WAS FOUND ON THE PLASTIC BLUE BASIN IN THE ANTERIOR HIP PACK (CDMH06E) PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM. THE BASIN AND SUPPLIES WERE THROWN AWAY AND A NEW STERILE FIELD WAS SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93981 ACS GENERAL SURGERY TRAY LRP AMERICAN CONTRACT SYSTEMS, INC. CDMH06E 654181 00191072029324

    Patients

    Seq Age Sex Outcome Treatment
    1 31390 DA