BEUDAMED
    FDA Adverse Event Other Summary report: N

    QWIK CONNECT SPIRAL

    MDR report key: 185155 · Received August 31, 1998

    Report

    Report Number
    185155
    Event Type
    Other
    Date Received
    August 31, 1998
    Date of Event
    August 18, 1998
    Report Date
    August 26, 1998
    Manufacturer
    COROMETRICS
    Product Code
    KXO
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ASSESSMENT OF NEWBORN, A LACERATION APPROX 1 CM WIDE WAS NOTED IN THE LEFT PARIETAL REGION OF THE HEAD WHICH WAS SUTURED USING 1 STITCH. CAUSE UNK. BOTH AN INTERNAL LEAD AND AN INTRAUTERINE PRESSURE CATHETER WAS USED DURING THE LABOR. BOTH MFRS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIK CONNECT SPIRAL COROMETRICS KXO COROMETRICS * 36V0
    2 SOFTRANS INTRAUTERINE PRESSURE CATH KXO GRAPHIC CONTROLS 31103826 073198

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other