BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8273225 · Received January 24, 2019

    Report

    Report Number
    8273225
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    December 21, 2018
    Report Date
    December 27, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    UDI-DI
    00191072046109
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR, POSSIBLY EYELASH OR EYEBROW, WAS DISCOVERED IN THE BLUE BASIN IN THE PACK DURING SETUP. CONTAMINATED PACK WAS REMOVED AND DISCARDED. NEW PACK OBTAINED TO RESET STERILE FIELD. NO PATIENT EXPOSURE TO CONTAMINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69326 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDEX31D 683181 00191072046109

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA