MAUDE Adverse Event Report: LIFEWAVE INC. LIFEWAVE PATCH; ADHESIVE BACKED THERMAL SKIN PATCHES

Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Depression (2361); Cancer (3262)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I started using the x39 and aeon patch from lifewave.I was told these would shrink my tumor.I had an mri done around (b)(6) of 2024 and my brain tumor was stable.My dad started the patches as well for his skin cancer.I was sick for several months on the patches.Something felt off i had another mri done in (b)(6) 2025 along with labs, my blood pressure was high, my tumor had started to grow.Nothing changed buy using lifewave patches.I stopped taking them and started to feel much better.But now i need another mri to measure growth rate.My dad called me last week, he had surgery on his chest to remove cancer and the cancer he had removed grew back on his hand.I told him to stop the patches.I have many screenshot of reps posting the patches heal, cure cancer.I also have screen shots of people saying the patches activate the cancer stem cells and their cancer came back.I have been trying to work this out with lifewave and all they have been doing is, deleting all the evidence and posting on zoom and signal.I was mislead and my elderly dad was taken advantage of.I'm now depressed and lost hope with my tumor.This, has been a huge overwhelming emotional process.I was told these are fda approved medical devices.I was told they cure cancer and heal diseases.I been lied to.I was told when i complained they are not working to add or buy more patches, which made me more sick.Than i was told to take dog wormer and not drink coffee.I was also told to not share zoom videos as they are non compliant by a big rep (b)(4).And dr (b)(6) who isn't a medical doctor but deals with herbs or natural remedies.I have over 59 screenshots as proof lifewave will not compensate me or my dad.They are just deleting all evidence.

• Brand Name: LIFEWAVE PATCH
• Common Device Name: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE INC.
• MDR Report Key: 22338267
• Report Number: MW5171944
• Device Sequence Number: 15004607
• Product Code: OMW
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ST JOHN'S PROBIOTICS ; BIOCELL COLLAGEN; BOSWELLIA; COQ10; FLAXSEED; GARLIC; KELP; LUETIN; PROBIOTICS; VIT C; VIT D
• Outcome Attributed to Adverse Event: Life Threatening; Disability
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White