BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8309934 · Received February 6, 2019

    Report

    Report Number
    8309934
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 21, 2019
    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

    CMC LAPAROSCOPY PACK #CDLS14D HAD A PACK OF X-RAY DETECTABLE SPONGES THAT HAD 11(ELEVEN) SPONGES INSTEAD OF 10 (TEN). IDENTIFIED ON INITIAL COUNT. DOES NOT MEET PATIENT SAFETY BEST PRACTICE STANDARDS; RADIOPAQUE SPONGES COME IN MULITPLES OF 10 AS A NATIONAL STANDARD CONTRIBUTING TO THE PREVENTION OF SURGICAL RETAINED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105345 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDLS14D 695181

    Patients

    Seq Age Sex Outcome Treatment
    1