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

Health Effect - Clinical Codes	Headache (1880); Pain (1994)
Date of Event	04/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I am a family medicine doctor in (b)(6) but in this situation also the consumer.I tried the lifewave x39 patches that i was gifted from a friend trying to help with my chronic ankle pain.I couldn't find much info at all on it (other than testimonials and very vague product description- its not supposed to contain any active medications in it) so figured it was pretty benign and gave it a try.On my second patch i developed a sudden severe migraine that only got worse with my triptan medication.Ended up in er and had to take multiple medications for pain control.Thankfully negative ct/cta.I'm wondering if there is actually something (a drug) in medication that particularly interfered with my triptan.I couldn't find any safety studies on it or contraindications.Unfortunately er doctor did not do drug screen.
Event or Problem Description
I am a family medicine doctor in (b)(6) but in this situation also the consumer.I tried the lifewave x39 patches that i was gifted from a friend trying to help with my chronic ankle pain.I couldn't find much info at all on it (other than testimonials and very vague product description- its not supposed to contain any active medications in it) so figured it was pretty benign and gave it a try.On my second patch i developed a sudden severe migraine that only got worse with my triptan medication.Ended up in er and had to take multiple medications for pain control.Thankfully negative ct/cta.I'm wondering if there is actually something (a drug) in medication that particularly interfered with my triptan.I couldn't find any safety studies on it or contraindications.Unfortunately er doctor did not do drug screen.
Event or Problem Description
Additional information received on 05/10/2023 for mw5117234.Updating procode and device manufacturer.

• Brand Name: LIFEWAVE X39 PATCHES
• Common Device Name: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE, INC.; 9775 businesspark ave; san diego CA 92131
• MDR Report Key: 16868825
• Report Number: MW5117234
• Device Sequence Number: 3613890
• Product Code: OMW
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023
• 2 Devices were Involved in the Event: 1 2

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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/10/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CALCIUM ; CALCIUM ; MAXALT AS NEEDED; MAXALT AS NEEDED; PROGESTIN BIRTH CONTROL ; PROGESTIN BIRTH CONTROL ; PROTONIX; PROTONIX; TRIPTAN ; TRIPTAN ; VITAMIN D; VITAMIN D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic
• Patient Race: White