BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMUKIN-D

    MDR report key: 269485 · Received March 9, 2000

    Report

    Report Number
    8021034-1999-00003
    Event Type
    Other
    Date Received
    March 9, 2000
    Date of Event
    February 28, 1998
    Report Date
    March 5, 1998
    Manufacturer
    AMUCHINA S.P.A.
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS FEVERISH DURING DIALYSIS. A GRAM-NEGATIVE BACTERIA WAS ISOLATED FROM THE BLOOD CULTURE TAKEN AFTER HEMODIALYSIS USING A REPROCESSED F-8 POLYSULFONE DIALYZER MFG BY FRESENIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMUKIN-D DISINFECTANT FOR REPROCESSING LRJ AMUCHINA S.P.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ANTIBIOTICS ON REGULAR BASIS FOR ON/OFF LOW GRADE| FEVER.