MAUDE Adverse Event Report: NEURENT MEDICAL LTD. NEUROMARK SYSTEM; RADIOFREQUENCY PROBE

Model Number FS-002-00

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

Patient Problem Epistaxis (4458)

Event Date 09/03/2022

Event Type  Injury  

Event Description

A patient treated with the neuromark system presented with acute right sided epistaxis 23 days post procedure.Sphenopalatine artery (spa) ligation was performed.The adverse event is resolved.

Manufacturer Narrative

Bleeding is a known potential adverse event and is documented in the device labelling.

• Brand Name: NEUROMARK SYSTEM
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): NEURENT MEDICAL LTD.; no. 1 oranpoint; oranmore; galway, H91 D 7X2; EI H91 D7X2
• Manufacturer (Section G): NEURENT MEDICAL LTTD; no. 1 oranpoint; oranmore; galway, H91D7 X2; EI H91D7X2
• Manufacturer Contact: kenny walsh ; no. 1 oranpoint; oranmore; galway, H91D7-X2 ; EI H91D7X2
• MDR Report Key: 15519624
• MDR Text Key: 300993714
• Report Number: 3016813990-2022-00002
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FS-002-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White