MAUDE Adverse Event Report: MONICA HEALTHCARE LIMITED NOVII; UTERINE ELECTROMYOGRAPHIC MONITOR

Model Number 107-PT-004

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Discharge (2225); Injury (2348)

Event Date 08/26/2017

Event Type  malfunction  

Event Description

The patient was using the monica novii device for fetal monitoring.When the patches were removed, there was an open and abraded area under each of the four patches on the patient's abdomen.Two of the areas were weeping and required a dressing.The wounds were approximately 3 cm x 3 cm each.Scratch marks were visible from the use of the 3m red dot trace prep, which was used prior to patch placement.The peel and stick pads were adhered around 10:30 a.M.And removed around 10 p.M.In follow up, the nurse manager reviewed the novii patch instructions, which indicates to inform the patient that the patch may cause skin irritation and to report any pain or burning at the skin site where the patch is used.This information was discussed with the team members involved and this process was reviewed.

• Brand Name: NOVII
• Type of Device: UTERINE ELECTROMYOGRAPHIC MONITOR
• Manufacturer (Section D): MONICA HEALTHCARE LIMITED; darrell lyndsey; 3862 brentview pl nw; kennesaw GA 30144
• MDR Report Key: 6854498
• MDR Text Key: 85625673
• Report Number: 6854498
• Device Sequence Number: 1
• Product Code: OSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 107-PT-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 3M RED DOT TRACE PREP (2236) PART NO, 100-PT-007 U
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 126