BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8407232 · Received March 11, 2019

    Report

    Report Number
    8407232
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 27, 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

    A HAIR WAS FOUND IN THE CMC EXTREMITY PACK PRIOR TO THE PATIENT ENTERING THE ROOM. STATED THAT THE HAIR WAS FOUND ON INSIDE FOLD AREA OF THE PACK. THE PACK WAS REMOVED FROM THE ROOM. A NEW ONE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203206 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDEX31D 990191 00191072046109

    Patients

    Seq Age Sex Outcome Treatment
    1