BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NMC FREEDOM CYCLER

    MDR report key: 34992 · Received July 9, 1996

    Report

    Report Number
    45129-1996-00215
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTEDLY IN HOSP WITH PERITONITIS; HAS BEEN HAVING TROUBLE USING THE DEVICE. SERVICE TECH REPORTS CYCLER DID NOT CAUSE OR CONTRIBUTE TO PERITONITIS; HOWEVER, UNABLE TO REACH PT TO DETERMINE WHETHER PERITONITIS EXISTED AT THE SAME TIME AS THE TROUBLE WITH CYCLER. FILED CONSERVATIVELY AS DISTRIBUTOR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMC FREEDOM CYCLER CYCLER KPF FRESENIUS USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention