BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO IAF 175 DIALYZER

    MDR report key: 14675 · Received March 4, 1994

    Report

    Report Number
    2243621-1994-05033
    Event Type
    Other
    Date Received
    March 4, 1994
    Date of Event
    February 7, 1994
    Report Date
    February 10, 1994
    Manufacturer
    TERUMO COROPORATION
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD NO COMPLAINTS PRE TREATMENT. ONE HR AFTER INITIATION OF TREATMENT, SHE COMPLAINED OF SEVERE ITCHING. 75MG OF SOLU-CORTIF WERE GIVEN IV. THE TREATMENT WAS DISCONTINUED AND THE SYMPTOMS SUBSIDED. THE PT WENT HOME. SHE RETURNED THE NEXT DAY AND WASSSSSSS DIALYZED ON AN F-6 DRY PACK DIALYZER WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO IAF 175 DIALYZER HOLLOW FIBER HEMODIALYZER FJI TERUMO COROPORATION TAF 175 (HF/CR/ 1.75/M) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other