BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CONNECT SPIRAL ELECTRODE

    MDR report key: 25538 · Received August 8, 1995

    Report

    Report Number
    25538
    Event Type
    Malfunction
    Date Received
    August 8, 1995
    Date of Event
    December 5, 1994
    Report Date
    January 6, 1995
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    HGP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT NEEDED TO HAVE FETAL SCALP ELECTRODE PLACED. RESIDENT PLACED FSE AND SMALL WIRE CLIP BROKE OFF IN FETAL SCALP. NEW ELECTRODE PLACED. PART REMOVED WITHOUT DIFFICULTY AFTER BABY WAS BORN, BY NURSERY NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CONNECT SPIRAL ELECTRODE FETAL SCALP ELECTRODE HGP COROMETRICS MEDICAL SYSTEMS, INC. 30A2

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other