MAUDE Adverse Event Report: NMA NEUROMONITORING; NEUROSURGICAL NERVE LOCATOR

Lot Number 1000-L

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 a minor burn to the medial aspect of the left leg.Nma neuromonitoring machine was used.Diagnosis or reason for use: acquired scoliosis.Nma, (b)(6).

• Brand Name: NMA NEUROMONITORING
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• MDR Report Key: 8888914
• MDR Text Key: 154898908
• Report Number: MW5088987
• Device Sequence Number: 1
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1000-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 41