MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE; BIOWAVE NONINVASIVE ELECTRODES

Model Number	BWEN01-B
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of electrodes showed sear marks (burn marks) over a half inch length along the edge of each electrode, through all of the layers of the electrodes.The black burn marks on both electrodes indicate that the electrodes were physically touching at the location.This is the only way that these burn marks can occur.Further evaluation of electrodes show that these pads were not new as the patient claimed.Rather these electrodes show numerous depressions in the hydrogel indicating that they had been used well beyond their useful life.
Event or Problem Description
Patient completed 30 minute treatment.One and half hour later he observed/experienced a burning sensation & realized he got a burn.He mentioned using the neurostimulator at 40-50% range intensity.Also that he was using brand new electrodes.

• Brand Name: BIOWAVE
• Common Device Name: BIOWAVE NONINVASIVE ELECTRODES
• Manufacturer (Section D): BIOWAVE CORPORATION; 8 knight street; norwalk CT 06851
• Manufacturer Contact: nuvati koppusetty ; 8 knight street; norwalk, CT 06851
• MDR Report Key: 21350018
• Report Number: 3004558433-2025-00001
• Device Sequence Number: 15704144
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2025
• Device Model Number: BWEN01-B
• Device Lot Number: 331464
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male