MAUDE Adverse Event Report: LIFEWAVE, INC. LIVEWAVE GLUTATHIONE X39 PATCH; ADHESIVE BACKED THERMAL SKIN PATCHES

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

Patient Problems Emotional Changes (1831); Pain (1994); Tinnitus (2103); Blurred Vision (2137); Chills (2191); Dizziness (2194); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553); Weight Changes (2607); Unspecified Gastrointestinal Problem (4491)

Event Date 03/14/2023

Event Type  Injury  

Event Description

Lifewave glutithoine and x39 patches please call me.Told was a detox patch from a vendor.Had it in my neck about three hours.Learned later it something with stem cells rejuvenated.Weird theory company claims it non invasive.However, it goes through the skin and wrecks on the brain and spine i believe.Changing cells dna and genetic makeup.Use as a skin repair.It said to contain copper peptides and gluithione? it much more clearly,suppose to reflect light.Think it falls under some technology that alters the body birth genes, please call me private number (b)(6).I have major health issues, weight, lost insomnia, chills, neck cracking, backaches, ringing in ear, flu like symptoms, dizzy, blurred vision neurological damage, gut issues, brain fog, mental health issues all in a matter of three weeks,.It is dangerous.I want this confidential and a call back.Will only fill out so much info on me.Causes over sensory in all senses.Tried calling (b)(6) and looked at youtube reviews did not know this was not fda approved.Talked to vendor and they stated it nothing in it just light reflect the patch to go to work targeting cell that need repair.Still confusing, company is also in other countries with other patches sold.I want to know who makes them formal and if you can test them.See what is in them asap.One of the owners i found on youtube will not call back.I want the patches tested.I want to know if it ant type of heavy metal, radioactive, or a other experimental substances.Could be some type test.Detox was told.

Event Description

Additional information received on 05/10/2023 for mw5117233.Updating procode and device manufacturer.

• Brand Name: LIVEWAVE GLUTATHIONE X39 PATCH
• Type of Device: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE, INC.; 9775 businesspark ave; san diego CA 92131
• MDR Report Key: 16868461
• MDR Text Key: 314627119
• Report Number: MW5117233
• Device Sequence Number: 1
• Product Code: OMW
• 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,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: GLUTATHIONE ; STEM CELLS PATCH; TAKE ALL VITAMIN A,B, C, D , E
• Patient Outcome(s): Disability; Other
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White