MAUDE Adverse Event Report: LIFEWAVE, INC. X39/ S6/AEON; ADHESIVE BACKED THERMAL SKIN PATCHES

Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Bought lifewave weight loss and stem cell patches on (b)(6) 2023 by (b)(6) 2024 i was drinking 1 bottle of water every half hour went to urgent care my blood pressure usually 120 now 170 heart rate 105.Weight loss and rejuvenating.

• Brand Name: X39/ S6/AEON
• Common Device Name: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE, INC.; 9775 businesspark ave; san diego CA 92131
• MDR Report Key: 18613853
• Report Number: MW5150906
• Device Sequence Number: 2524795
• Product Code: OMW
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

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: 01/30/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALASKAN FISH OIL ; CENTRUM; HYZAAR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian