BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISTRIBUTED DIALYZER

    MDR report key: 111438 · Received April 24, 1996

    Report

    Report Number
    2243621-1996-07124
    Event Type
    Injury
    Date Received
    April 24, 1996
    Date of Event
    February 15, 1995
    Report Date
    February 2, 1996
    Manufacturer
    *
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR/MDR FACILITY ALLEGES THE DIALYZER LEAKED ON REUSE #3. ECL < 100 C.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention