BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 11893242 · Received May 27, 2021

    Report

    Report Number
    1218950-2021-10603
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 19, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    HGP
    UDI-DI
    20884838007431
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THIS COMPLAINT EVALUATION, AND THE CUSTOMER RESOLUTION AND DISPOSITION BUT ATTEMPTS HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS LATER OBTAINED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT FETAL SPIRAL ELECTRODE CAUSED DAMAGED TO THE NEWBORN HEAD.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FSE CAUSED DAMAGED TO THE NEWBORN HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789572 FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE HGP PHILIPS NORTH AMERICA LLC 989803137631 20884838007431

    Patients

    Seq Age Sex Outcome Treatment
    1 Other