BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 1884064 · Received October 20, 2010

    Report

    Report Number
    8030665-2010-00030
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    August 1, 2009
    Report Date
    October 21, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT'S WIFE REPORTED THAT HER HUSBAND WAS DIAGNOSED WITH PERITONITIS IN (B)(6) 2009. NO FURTHER INFO WILL BE PROVIDED. NO PRODUCT DEFECT WAS REPORTED. THERE IS NO SAMPLE AND THE LOT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITNEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R LIBERTY CYCLER