BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISTRIBUTED DIALYZER

    MDR report key: 111176 · Received April 24, 1996

    Report

    Report Number
    2243621-1996-06683
    Event Type
    Injury
    Date Received
    April 24, 1996
    Date of Event
    November 5, 1993
    Report Date
    January 30, 1996
    Manufacturer
    *
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES DIALYZER CRACKED. ECL > 100CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DISTRIBUTED DIALYZER * FJI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention