MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SCALP ELECTRODES

Model Number CNS000004

Device Problem Difficult to Remove (1528)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The device was discarded; the lot number is not known.No further information will be made available but clinical innovations will continue to monitor and trend all reported events associated with this device.

Event Description

Problems removing the fetal scalp electrodes.According to the midwifes the scalp electrodes seems more tight than previous batch.Device caused big bald spots after placing the scalp electrodes three-times.They saw 5 babies with inflammations due to scalp electrodes.

• Brand Name: GOLDTRACE FETAL SCALP ELECTRODES
• Type of Device: FETAL SCALP ELECTRODES
• 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: andrea gadsby ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 8191387
• MDR Text Key: 131222252
• Report Number: 1722684-2018-00019
• Device Sequence Number: 1
• Product Code: HGP
• 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: 12/21/2018

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
• Device Operator: Health Professional
• Device Model Number: CNS000004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other