BEUDAMED
    FDA Adverse Event Death Summary report: N

    JMS APHERESIS NEEDLE

    MDR report key: 291023 · Received August 18, 2000

    Report

    Report Number
    8031563-2000-00001
    Event Type
    Death
    Date Received
    August 18, 2000
    Report Date
    July 27, 2000
    Manufacturer
    JMS CO., LTD.
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE LETTER FROM THE USER DATED 07/08/2000, A DONOR WHO DONATED BY PLASMA-PHERESIS ON 05/28/2000 DIED ON 06/02/2000. THE LETTER WAS REC'D BY JMS ON 07/21/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JMS APHERESIS NEEDLE 16GX11/4" BACK EYE GKT JMS CO., LTD. 820-1624 9900113511

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death