BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDIA

    MDR report key: 12939 · Received March 28, 1994

    Report

    Report Number
    2243621-1994-05050
    Event Type
    Injury
    Date Received
    March 28, 1994
    Date of Event
    February 14, 1994
    Report Date
    March 14, 1994
    Manufacturer
    CGH
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES BLOOD LEAK. OCUURRED AT BEGINNING OF TREATMENT. EBL 100CC PATIENT RESTARTED ON NEW DIALYZER. NO FURTHER MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUNDIA HEMODIALYZER FKP CGH ICSL 30569N11

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention