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

Model Number CSN000004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 08/25/2015

Event Type  Injury  

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 Description

Use of goldtrace fse claimed to have permanently caused tissue damage to patient.

• Brand Name: GOLD TRACE FETAL SCALP ELECTRODE
• Type of Device: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: santosh bhagat ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 8016924
• MDR Text Key: 125431566
• Report Number: 1722684-2018-00014
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 00814247020505
• UDI-Public: 00814247020505
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSN000004
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1