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

Health Effect - Clinical Codes	Headache (1880); Syncope/Fainting (4411); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	08/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
My parents started lifewave patches and had me try them.I tried for one day and had the worst headache.Then i retried a few days later and had been using them through headaches for 3 days.I woke up with horrible menstrual cramps at 5 am on the 4th day almost passed out 5 times from the pain.I have very regular periods and this has never happened before and stopped when i took the patch off.Would love to know if you have more information on how/why this happened.I found out they use stem cells and have been researching.

• Brand Name: LIFEWAVE X39
• Common Device Name: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE, INC.; 9775 businesspark ave; san diego CA 92131
• MDR Report Key: 19998688
• Report Number: MW5158515
• Device Sequence Number: 8350691
• Product Code: OMW
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/11/2024

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White