MAUDE Adverse Event Report: NEUROMONITORING MACHINE ; NEUROSURGICAL NERVE LOCATOR

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

Patient Problem Burn, Thermal (2530)

Event Date 07/31/2019

Event Type  malfunction  

Event Description

Pt suffered minor burn to medial aspect of the left leg.Cautery machine and nma neuromonitoring machine used.Burn most likely related to the nma neuromonitoring machine as cautery was not used on the leg.Diagnosis or reason for use: cervical disc disorder with radiculopathy.

• Brand Name: NEUROMONITORING MACHINE
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• MDR Report Key: 8874421
• MDR Text Key: 154097484
• Report Number: MW5088899
• Device Sequence Number: 2
• Product Code: PDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 107