BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 4091261 · Received September 5, 2014

    Report

    Report Number
    8030665-2014-00722
    Event Type
    Injury
    Date Received
    September 5, 2014
    Report Date
    August 26, 2014
    Manufacturer
    FRESENIUS MED CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT (PERITONITIS AND SEPSIS) IS FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED MULTIPLE PERITONEAL INFECTIONS AND SEPSIS ON UNK DATES AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546315 LIBERTY CYCLER SET FKX FRESENIUS MED CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S