MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE NONINVASIVE ELECTRODES

Model Number BWENO1-B

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Rash (2033)

Event Date 05/28/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 339776073
• Report Number: 3004558433-2024-00003
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• Combination Product (y/n): N
• PMA/PMN Number: K152437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2022
• Device Model Number: BWENO1-B
• Device Lot Number: 115243
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/28/2023
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male