BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8568613 · Received May 1, 2019

    Report

    Report Number
    8568613
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 11, 2019
    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

    WHILE OPENING PACK FOR THE CASE THE SCRUB PERSON OPENED ONE SIDE OF THE WRAP AND FOUND A HAIR ON THE INSIDE OF THE DRAPE. THE PACK WAS REMOVED FROM USE AND A NEW PACK WAS OBTAINED. THIS OCCURRED PRIOR TO THE PATIENT ENTERING THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361412 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDEX31D 990191 00191072046109

    Patients

    Seq Age Sex Outcome Treatment
    1