BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 304232 · Received November 8, 2000

    Report

    Report Number
    2937457-2000-00059
    Event Type
    Injury
    Date Received
    November 8, 2000
    Date of Event
    October 11, 2000
    Report Date
    October 12, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED THAT A HOME PT TRIPPED AND SUSTAINED A CUT ABOUT 6 INCHES LONG ON THEIR FORARM WHEN THEY FELL AND HIT THE EDGE OF THE CYCLER STAND LEG. THE PLASTIC COVER WAS MISSING FROM THE STAND LEG. THE PT WAS TAKEN TO THE HOSP AND RECEIVED 23 STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CYCLER PD+ PERITONEAL DIALYSIS CYCLER KPF FRESENIUS MEDICAL CARE-NORTH AMERICA PD+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention