BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8159345 · Received December 13, 2018

    Report

    Report Number
    8159345
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 28, 2018
    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

    SURGICAL SAFETY ISSUE - STERILE SUPPLY PACK CONTAINED 11 RADIOPAQUE SPONGES INSTEAD OF THE NATIONAL STANDARD OF MULTIPLES OF 10. PER AORN STANDARDS, THE 11 WERE PASSED OFF THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001363 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDLP15C 750181

    Patients

    Seq Age Sex Outcome Treatment
    1