BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 3900459 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20672
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT (PT) EXPERIENCED AN ANAPHYLACTIC REACTION. IT WAS UNKNOWN IF MEDICAL INTERVENTION WAS PERFORMED FOR THIS PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377689 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD*

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SALINE