BEUDAMED
    FDA Adverse Event Other Summary report: N

    QWIK CONNECT SPIRAL ELECTRODE

    MDR report key: 187531 · Received September 14, 1998

    Report

    Report Number
    1216774-1998-00016
    Event Type
    Other
    Date Received
    September 14, 1998
    Date of Event
    August 18, 1998
    Report Date
    September 11, 1998
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    HGP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, UPON ASSESSMENT OF INFANT'S CONDITION FOLLOWING DELIVERY THERE WAS A 1 CENTIMETER LACERATION DISCOVERED ON THE INFANT'S HEAD. COROMETRICS' SPIRAL ELECTRODE WAS USED IN CONJUNCTION WITH LABOR AND DELIVERY MONITORING AND IS A SUSPECTED FACTOR IN THE CAUSE OF THE LACERATION. CUSTOMER STATES IN THEIR MEDWATCH REPORT THAT THE CAUSE OF THE LACERATION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIK CONNECT SPIRAL ELECTRODE SPIRAL ELECTRODE HGP COROMETRICS MEDICAL SYSTEMS, INC. NA 36VO

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R