BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 12727446 · Received November 1, 2021

    Report

    Report Number
    12727446
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 22, 2021
    Report Date
    October 25, 2021
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON SCRUBBED FOR SURGERY. WHEN DRYING HANDS WITH DISPOSABLE BLUE TOWEL FROM PACK, VISIBLE BLUE, FROM AMERICAN CONTRACT SYSTEMS GENERAL SURGERY TRAY, LINT FIBERS WERE NOTED ON HIS ARMS. TOWEL AND PACK CONTENTS SHEET WERE KEPT ASIDE AND MANAGER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626719 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. 736211

    Patients

    Seq Age Sex Outcome Treatment
    1