MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SCALP ELECTRODE; SPIRAL FETAL SCALP ELECTRODE

Model Number	CNS000004
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This particular patient required 2 separate fetal scalp electrodes to be placed due to lack of connectivity.Sometimes, if the first electrode is not applied securely enough or if the baby has a large amount of hair, it can interfere with the connectivity.Approximately, 3 days after delivery, the baby developed an infection on the scalp where the electrodes had been placed.Unfortunately, whenever there is a break in the skin, there is a risk for infection.The vagina is not a sterile environment, and infection can often develop because of this.There can also be an increased chance of infection depending on how long the fetal scalp electrode is in place during labor.
Event or Problem Description
Spontaneous partus (b)(6) 2018, in which two times a new scalp electrode was placed because of bad registration.On (b)(6) consultation in pediatrics concerning inflated swelling on the occiput of the neonate.Ultrasound was done: no corpus alienum, but pus visible.Infection treated with antibiotics.

• Brand Name: GOLDTRACE FETAL SCALP ELECTRODE
• Common Device Name: SPIRAL FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7871563
• Report Number: 1722684-2018-00012
• Device Sequence Number: 186866
• Product Code: HGP
• UDI-Device Identifier: 00814247020505
• UDI-Public: 00814247020505
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K030691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: CNS000004
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO