BEUDAMED
    FDA Adverse Event Death Summary report: N

    "REDY"

    MDR report key: 1031488 · Received April 17, 2008

    Report

    Report Number
    MW5006289
    Event Type
    Death
    Date Received
    April 17, 2008
    Product Code
    FKT
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWELVE DEATHS SINCE 2008 AT HOSPITAL, ON DIALYSIS MACHINE, OR AFTER DIALYSIS. DIAGNOSIS OR REASON FOR USE: DIALYSIS. MACHINE CLEANED AFTER EACH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "REDY" DIALYSIS MACHINE FKT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death