MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE NONINVASIVE ELECTRODES; BWEN01-B

Lot Number	328671
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon reviewing the photographs of the electrodes, it is evident that the wire of the electrode has been pulled out, resulting in the exposure of the metal/wire part.This exposed section came into direct contact with the patient's skin, causing a blister.Additionally, the electrodes exhibit significant signs of wear and tear.The hydrogel layer appears very thin, exposing the underlying electrode.When the power button is pressed on all devices, a continuous 1-volt signal is sent to the pads and returned to the device to ensure a complete circuit and verify that the treatment is ready to commence.Typically, most individuals cannot perceive the sensation of a 1-volt signal with noninvasive pads.However, some may feel a slight tingling sensation, which is not a shock.In this case, the patient experienced a shock because defective electrodes were used with the device.Therefore, it is concluded that the actual issue lies with the electrodes themselves.
Event or Problem Description
The patient got burns on his left hip; patient said he was lying down on a side with his hip up in the air; skin was clean, and the electrodes were sticky.He said he didn't move during the treatment; the unit was placed on the table.A few seconds before the full treatment was done unit flashed triangle.He had stimulation at 50% for the whole treatment.
Additional Manufacturer Narrative
The device is waiting to be shipped by customer.Once biowave receives the device associated with this injury, we will carry out further investigation to narrow down the root cause.
Event or Problem Description
The patient got burns on his left hip; patient said he was lying down on a side with his hip up in the air; skin was clean, and the electrodes were sticky.He said he didn't move during the treatment; the unit was placed on the table.A few seconds before the full treatment was done unit flashed triangle.He had stimulation at 50% for the whole treatment.

• Brand Name: BIOWAVE NONINVASIVE ELECTRODES
• Common Device Name: BWEN01-B
• Manufacturer (Section D): BIOWAVE CORPORATION; 3 brook st; norwalk CT 06851
• Manufacturer Contact: nuvati koppusetty ; 3 brook st; norwalk, CT 06851
• MDR Report Key: 19377079
• Report Number: 3004558433-2024-00005
• Device Sequence Number: 12646862
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 00859911006089
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 09/27/2025
• Device Lot Number: 328671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male