BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER

    MDR report key: 2210682 · Received August 5, 2011

    Report

    Report Number
    1713747-2011-00030
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 5, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A REPORT HAS BEEN REC'D THAT REPORTED A POSSIBLE DIALYZER ALLERGIC REACTION. FOR THIS EVENT, IT WAS REPORTED THAT THE PT REC'D DIPHENHYDRAMINE INTRAVENOUSLY FOR ITCHING. THE MEDICATION WAS ADMINISTERED AT THE START OF THE TREATMENT. THE PT CONTINUED TO REPORT SOME ITCHING DURING DIALYSIS AS WELL AS AFTER DIALYSIS. THE PT COMPLETED DIALYSIS WITH USE OF THIS DIALYZER AND WAS DISCHARGED TO HOME. THERE IS NO SAMPLE AND THE LOT IS UNK. THE PT CONTINUED TO RECEIVE DIALYSIS WITH USE OF THIS DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER DIALYZER FJI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R