BEUDAMED
    FDA Adverse Event Other Summary report: N

    .020" NITINOL GUIDEWIRE

    MDR report key: 241930 · Received September 24, 1999

    Report

    Report Number
    2248146-1999-00031
    Event Type
    Other
    Date Received
    September 24, 1999
    Report Date
    September 21, 1999
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ORDERED PART NUMBER 0684-00-0254-04 (.020 NITINOL GUIDEWIRES), WHICH IS THE PART NUMBER LABELED ON THE OUTSIDE OF THE BOX. WHEN THE BOX WAS OPENED THEY FOUND PART NUMBER 0684-19-0052 (.030 STAGED GUIDEWIRES). EVENT COMPLICATIONS: NEVER USED ON PT - REPORTED 9/21/99. PT'S CURRENT STATUS: NA - REPORTED 9/21/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .020" NITINOL GUIDEWIRE GUIDEWIRE DQX DATASCOPE CORP. 0684-00-0254-04 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other