BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVY CORNUAL CANNULATION SET

    MDR report key: 2190981 · Received July 29, 2011

    Report

    Report Number
    1825146-2011-00029
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    MOV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR A PROPER EVALUATION. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO OBTAIN INFORMATION WITHOUT SUCCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A NOVY CORNUAL CANNULATION SET DURING AN HSG/SSG PROCEDURE. WHILE NAVIGATING THE CATHETER WITHIN THE PATIENT TO GET THE CATHETER IN PLACE TO EXPEL THE CONTRAST MEDIA, THE GUIDE TIP (3/4 INCH) FELL OFF INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE THE TIP. THE PROCEDURE HAD TO BE REDONE WITH A NEW NOVY CORNUAL CANNULATION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVY CORNUAL CANNULATION SET MOV CATHETER, SALPINGOGRAPHY MOV COOK UROLOGICAL, INC. NA U2066978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HYSTEROSCOPE