BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 4101094 · Received September 17, 2014

    Report

    Report Number
    8030665-2014-00738
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    April 1, 2009
    Report Date
    August 28, 2014
    Manufacturer
    FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG
    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 IS ONE EVENT (PERITONITIS - SEPSIS) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTY ALLEGED THAT THE PLAINTIFF EXPERIENCED MULTIPLE INSTANCES OF PERITONEAL INFECTIONS AND SEPSIS ON UNK DATES IN (B)(6) 2009 AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576695 LIBERTY CYCLER SET FKX FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG

    Patients

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