BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1912320 · Received November 3, 2010

    Report

    Report Number
    1713747-2010-00048
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K874872
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED IS THAT THE PT WEIGHED (B)(6) AND THE REPORTED BLOOD LOSS WAS 50CCS. THE PT WAS GIVEN ANTIBIOTICS AS A PROPHYLACTIC MEASURE AND THEN SENT HOME, WAS NOT ADMITTED. THIS PT RECEIVED DIALYSIS ON AN OUTPATIENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FJI OGDEN MANUFACTURING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS DIALYSIS MACHINE-(B)(4)