BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8296533 · Received February 1, 2019

    Report

    Report Number
    8296533
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 23, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROOM SET UP FOR PROCEDURE THE STERILE PACK WAS OPENED AND A BLACK DOT WAS SEEN ON THE TOP SIDE OF THE TABLE DRAPE INSIDE THE PACK. THE DOT SMEARED ACROSS THE DRAPE UPON FURTHER INSPECTION AFTER IT WAS REMOVED FROM USE. THE PACK WAS REMOVED. A NEW PACK WAS OPENED AND USED. THIS OCCURRED PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90349 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDEX31C 732181

    Patients

    Seq Age Sex Outcome Treatment
    1