BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRES F8 (HF/PS/1.8/M)

    MDR report key: 105835 · Received April 24, 1996

    Report

    Report Number
    2243621-1996-04668
    Event Type
    Injury
    Date Received
    April 24, 1996
    Date of Event
    September 12, 1994
    Report Date
    January 9, 1996
    Manufacturer
    FRESENIUS USA INC
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR, FACILITY ALLEGES DIALYZER CLOTTING. UNABLE TO RET PT BLOOD. EBL > 100CC. FACILITY DENIES PT INJURY. TREATMENT REINITIATED AND NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRES F8 (HF/PS/1.8/M) DIALYZER KDI FRESENIUS USA INC * ECC2931

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention