BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEWLETT PACKARD DISPOSABLE SPIRAL ELECTRODE FOR FETAL MONITR

    MDR report key: 85933 · Received July 1, 1996

    Report

    Report Number
    85933
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    February 9, 1996
    Report Date
    March 27, 1996
    Manufacturer
    HEWLETT-PACKARD CO
    Product Code
    HGP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF INTERNAL SPIRAL ELECTRODE USED FOR FETAL MONITORING BROKE OFF AND REMAINED IN INFANT'S SCALP. TIP WAS REMOVED BY A SURGICAL INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD DISPOSABLE SPIRAL ELECTRODE FOR FETAL MONITR DISPOSABLE SPIRAL ELECTRODE FOR FETAL MONITOR HGP HEWLETT-PACKARD CO HP 15133A 30J7

    Patients

    Seq Age Sex Outcome Treatment
    1 00 DAY Required Intervention