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

Model Number	CNS000004
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Also information was provided that one child required stitches to repair a place on the baby's scalp that was bleeding after the scalp electrode was removed at delivery.Some of the factors that can contribute to this are: the scalp electrode was not placed and/or removed per our ifu's.The electrode placed in an incorrect location on the baby's scalp.The baby have any clotting or bleeding disorders that could have contributed to the bleeding.
Event or Problem Description
The goldtrace electrodes have at multiple occasions caused unusually difficult marks in the scalp in recent months.The blood flow where the electrode was stuck had to be sewn on one of the children.And 2 children have had an infection that led to an abscess.The abscess had to be opened and the child has received an antibiotic cure.Other causes of blood flow and inflammation have not been found.

• 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: 7871562
• Report Number: 1722684-2018-00013
• Device Sequence Number: 228452
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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: Health Professional
• 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