BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2223912 · Received August 19, 2011

    Report

    Report Number
    1713747-2011-00040
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    OGDEN MFG.
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY HAS BEEN CONTACTED FOR ADD'L INFO. IT WAS LEARNED THAT THE PT REPORTED FEELING LIKE SHE WAS GOING TO PASS OUT. THE PT CURRENTLY RECEIVES SUBSEQUENT DIALYSIS WITH USE OF THIS DIALYZER WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE. OF NOTE: AS OF TODAY, NO FURTHER INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FJI OGDEN MFG. NA 11BU01001

    Patients

    Seq Age Sex Outcome Treatment
    1