BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO

    MDR report key: 23837 · Received December 18, 1993

    Report

    Report Number
    2243621-1993-00246
    Event Type
    Injury
    Date Received
    December 18, 1993
    Date of Event
    November 13, 1993
    Report Date
    December 3, 1993
    Manufacturer
    TERUMO CORPORATION
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES PT REACTION DURING DIALYSIS. PT C/O OF CHILLS. TEMP UP FROM 97.8 FROM 97.8 DEGREES TO 102.1 DEGREES F. TREATMENT DISCONTINUED. NO FURTHER MEDICAL INTERVENTION REQUIRED. 6TH USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO HEMODIALYZER FJI TERUMO CORPORATION T175 889019

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention