BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008 MACHINE

    MDR report key: 3792891 · Received April 3, 2014

    Report

    Report Number
    3792891
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INAPPROPRIATE SALINE BAG FILING OF QUESTIONABLE SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203297 2008 MACHINE 2008 MACHINE FII 115496
    203298 SALINE SALINE KDI 13JUL06062
    203299 TUBING TUBING FJK 13PRO1262
    203300 DIALYZER DIALYZER KDI 13PU01008 F160NR

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR