MAUDE Adverse Event Report: ELECTRONIC WAVEFORM LAB, INC. H-WAVE; STIMULATOR, MUSCLE, POWERED

Model Number H4

Patient Problems Headache (1880); Burning Sensation (2146); Arthralgia (2355)

Event Date 09/20/2023

Event Type  Injury  

Event Description

I was using the h-wave device as per instructions on a video conference with an h-wave representative.The device caused severe pain in my joints that were in the treatment area as well as a severe burning sensation in my spine outside of the treatment area, and a migraine.These effects have lasted, thus far, for 3 hours, and have no indication of reducing, despite taking pain relieving medications such as codeine.

• Brand Name: H-WAVE
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): ELECTRONIC WAVEFORM LAB, INC.
• MDR Report Key: 17810348
• MDR Text Key: 324273154
• Report Number: MW5146113
• Device Sequence Number: 1
• Product Code: IPF
• 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
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: H4
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CODEINE.; FOLATE.; IBUPROFEN.; MAGNESIUM.; MONTELUKAST.; TIZANIDINE.
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White