BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8343099 · Received February 15, 2019

    Report

    Report Number
    8343099
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 8, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    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

    AFTER PULLING THE BLUE WRAPPED PACK (ANTERIOR HIP PACK) OUT OF THE CLEAR PACKING A STREAK OF WHAT APPEARED TO BE DRIED BLOOD WAS FOUND ON THE STICKER THAT KEEPS THE BLUE WRAP TOGETHER. THE PACK WAS TAKEN TO THE QUALITY OFFICE. NEW PACK OBTAINED. THIS OCCURRED PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137938 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDMH06E 654181 00191072029324

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA