BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3760972 · Received April 11, 2014

    Report

    Report Number
    1036844-2014-00173
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THIS REPORT WAS SUBMITTED WITH VERY LIMITED INFORMATION. IT WAS REPORTED THAT "PLACER PUNCTURED ATRIUM UPON INSERTION OF DEVICE. NO OTHER DETAILS WERE GIVEN. NO SAMPLE WAS RETAINED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220918 UNKNOWN UNKNOWN DQY ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention