BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3250835 · Received July 29, 2013

    Report

    Report Number
    1722028-2013-01306
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 21, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK970005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354784 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET, GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other