BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SET W/PRE-FILLED DISINFECTW/SN

    MDR report key: 34886 · Received July 9, 1996

    Report

    Report Number
    45129-1996-00214
    Event Type
    Injury
    Date Received
    July 9, 1996
    Report Date
    July 2, 1996
    Manufacturer
    FRESENIUS USA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME CARE COORDINATOR ALLEGES SPLIT DRAIN BAG. EFFLUENT SPILLED TO FLOOR. PT DEVELOPED PERITONITIS 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SET W/PRE-FILLED DISINFECTW/SN DIALYSIS SET WITH DISINFECTANT KPF FRESENIUS USA NA 070116D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention