BEUDAMED
    FDA Adverse Event Other Summary report: N

    .020" NITINOL GUIDEWIRE

    MDR report key: 242330 · Received September 27, 1999

    Report

    Report Number
    2248146-1999-00033
    Event Type
    Other
    Date Received
    September 27, 1999
    Report Date
    September 24, 1999
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE BOX OF GUIDEWIRES LABELED PART NUMBER 0684-00-0254-04 (.020 NITINOL GUIDEWIRES) WHICH IS THE PART NUMBER LABELED ON THE OUTSIDE OF THE BOX WAS OPENED, PART NUMBER 0684-19-0052 (.030 STAGED GUIDEWIRES) WERE IN THE BOX. THIS EVENT OCCURRED WHEN THE DATASCOPE SALESPERSON RECEIVED THE BOX OF GUIDEWIRES AT HIS HOME. WIRES WERE NEVER USED AT THE FACILITY. EVENT COMPLICATIONS: NEVER USED ON A PT - REPORTED 9/24/99. PT'S CURRENT STATUS: NA - REPORTED 9/24/99.

    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