BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEMOTO INJECTOR DUAL SHOT

    MDR report key: 3326575 · Received August 9, 2013

    Report

    Report Number
    2126677-2013-00016
    Event Type
    Injury
    Date Received
    August 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    July 10, 2013
    Manufacturer
    NEMOTO KYORINDO CO., LTD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. IF ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4) WAS NOTIFIED OF AN EVENT REGARDING THE POTENTIAL INVOLVEMENT OF A MEDICAL DEVICE DISTRIBUTED BY (B)(4) (NEMOTO CONTRAST DELIVERY SYSTEM: DUAL SHOT ALPHA), IN EVENT (S) WHEREBY PTS HAVE RECEIVED AN INFECTION OF (B)(6). CT EXAMS (WITH USAGE OF CONTRAST MEDIA) WERE PROVIDED ON AN OPTIMA CT660 WITH A NEMOTO INJECTOR DUAL SHOT. DURING THESE EXAMINATIONS, THE CUSTOMER USED NON-ORIGINAL CONSUMABLES AND DID NOT APPLY CONSUMABLES 'SINGLE-USE' (ONE SYRINGE KIT, ONE PT) POLICY AS DIRECTED ON EACH PACKAGE. THE (B)(6) REP HAS BEEN INFORMED. THIS PRODUCT IS NOT MANUFACTURED BY (B)(4). (B)(4) IS THE IMPORTER OF THE NEMOTO INJECTOR DUAL SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381551 NEMOTO INJECTOR DUAL SHOT NEMOTO DXT NEMOTO KYORINDO CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other