MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE NONINVASIVE ELECTRODES

Model Number	BWENO1-B
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation revealed several factors contributing to the skin irritation experienced by the user: prolonged exposure to the electric pads or pressure on the skin: extended usage or excessive pressure on the skin can lead to irritation, particularly if proper precautions are not taken.Use of excessively high settings: setting the device at high intensity levels may exacerbate skin irritation or even cause welts, especially if not used in accordance with the recommended guidelines.Individual skin conditions: individuals with pre-existing skin conditions such as eczema or psoriasis may be more susceptible to developing adverse reactions when using the device.We couldn't get more information on the patient's skin condition.So, adding this as a possibility.Allergic reactions: it is possible that the user experienced allergic reaction to the hydrogel used in conjunction with the device.Furthermore, the investigation noted that the device exhibited heavy signs of usage, appearing worn and showing significant accumulation of dirt.These factors may have contributed to the user's experience of skin irritation.
Event or Problem Description
Unit/device is burning patient's back resulting in raised welts.Treatment with our device has helped but noticed thge welts one month before he reported this complaint to mnaufacturer.Patient tried the treatment with new set of electrodes and got same results.He doesnot fell any burbning sensation durimng treatment but sees welts after the treatment.

• Brand Name: BIOWAVE NONINVASIVE ELECTRODES
• Common Device Name: NONINVASIVE ELECTRODES
• Manufacturer (Section D): BIOWAVE CORPORATION; 8 knight st; suite 201; norwalk CT 06851
• Manufacturer Contact: nuvati koppusetty ; 8 knight st; suite 201; norwalk 06851
• MDR Report Key: 19074232
• Report Number: 3004558433-2024-00003
• Device Sequence Number: 6817028
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• Combination Product (Y/N): N
• PMA/510(K) Number: K152437
• 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
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/08/2022
• Device Model Number: BWENO1-B
• Device Lot Number: 115243
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2023
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male