BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRES F60A/A/B (JF/PS/1.2/H)

    MDR report key: 105950 · Received April 24, 1996

    Report

    Report Number
    2243621-1996-05063
    Event Type
    Injury
    Date Received
    April 24, 1996
    Date of Event
    May 1, 1993
    Report Date
    January 19, 1996
    Manufacturer
    FRESENIUS USA INC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT DIALYZER LEAKED ON 4TH USE. EBL < 100 CC. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRES F60A/A/B (JF/PS/1.2/H) * KDI FRESENIUS USA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention