MAUDE Adverse Event Report: SMALL LASER LIGHT; POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJ

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

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Neck Pain (2433)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to red light laser treatment she received for neuropathy pain in mid january.Patient stated that she saw it advertised in the newspaper and decided to try it.Patient stated when she went, a red-light laser was wrapped around the middle of her body and she would sit there for about 20-30 minutes, she did this a couple times a week.Patient stated after her second week of treatment she started experiencing neck pain on the side of her neck.Patient said when she went back for the next treatment a small laser light that produced a small amount of heat was used.Patient stated after that second laser treatment she felt like she was going to pass out.Patient said when she got home, she ate a snack and laid down for a couple hours.Patient said at her next treatment appointment she told the providing doctor about her experience and she did not get any laser treatment that day.Patient stated she decided to stop going to the treatment center.Patient says she still has dizziness in her head, she felt extremely tired for weeks following the laser treatment, and just didn't feel like herself.Patient stated she had increased blood pressure and just felt like she needed to sleep a lot.Patient stated it took a few weeks to feel back to herself.

• Brand Name: SMALL LASER LIGHT
• Type of Device: POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJ
• MDR Report Key: 11664109
• MDR Text Key: 245789417
• Report Number: MW5100775
• Device Sequence Number: 2
• Product Code: NHN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR