MAUDE Adverse Event Report: PLATINUM LED HOLDINGS LLC. PLATINUMLED THERAPY LIGHTS: BIOMAX 900; LAMP, INFRARED, THERAPEUTIC HEATING

Model Number BIOMAX 900

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Blister (4537)

Event Date 02/13/2022

Event Type  Injury  

Event Description

I purchased a biomax 900 red light therapy device from platinum led therapy at platinumtherapylights.Com, which on their site is advertised as an fda-approved class 2 medical device.I reviewed the instructions carefully prior to using the device, and followed the company's instructions regarding how far away to stand and how long to use the device (actually, i used it for even less time than was suggested).The third time i used the device (over the course of two weeks) it caused the skin on my face to blister.I am very concerned that using the device even more conservatively than the company suggested caused skin damage when red light is supposed to safe and healthy.I notified the company of this side effect, and they told me their light is safe when used correctly.They then told me to stand much further away from the light.I pointed out this did not align with their instructions for use and asked why they made such a powerful light (and advertise it as being "better" than lights with less power) if it's in fact dangerous to use as directed, but got no response.I took a photo of one of the blisters under my eye that this caused and am happy to submit it if needed.Fda safety report id # (b)(4).

• Brand Name: PLATINUMLED THERAPY LIGHTS: BIOMAX 900
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): PLATINUM LED HOLDINGS LLC.
• MDR Report Key: 15563090
• MDR Text Key: 301508372
• Report Number: MW5112499
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BIOMAX 900
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CHLOROPHYLL; CYMBALTA; MCT OIL; MULTIVITAMIN ; TRAZODONE; TURMERIC
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White