MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC GOLD TRACE FETAL SCALP ELECTRODE

Model Number	CSN000004
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/25/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical innovations learned through our distributor of this event that happened in 2015.Our distributor received a letter from the hospital where the event happened that was dated (b)(6) 2018.We are trying to gather more information if any is available.
Event or Problem Description
Use of goldtrace fse claimed to have permanently caused tissue damage to patient.

• Brand Name: GOLD TRACE FETAL SCALP ELECTRODE
• Common Device Name: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8016924
• Report Number: 1722684-2018-00014
• Device Sequence Number: 13726456
• 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): 10/24/2018

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: CSN000004
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1