MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE NON-INVASIVE ELECTRODES

Model Number	BWENO1-B
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the electrodes showed thin sections of hydrogel which resulted from overuse of the pads and possible improper storage.Thinner worn out sections of hydrogel can result in hot spots.Further more the evaluation shows the pads were not being used the first time as the patient claimed.
Event or Problem Description
Patient got burned by pads and later blisters were observed at pad side.Patient mentioned that he cleaned the area well and used new pads each time for the treatment, pads were placed at 1.5 inches apart.Blisters occured when the intensities were at 70% and 100%, twice.

• Brand Name: BIOWAVE NON-INVASIVE ELECTRODES
• Common Device Name: NON-INVASIVE ELECTRODES
• Manufacturer (Section D): BIOWAVE CORPORATION; 8 knight street; suite 201; norwalk CT 06851
• Manufacturer Contact: nuvati koppusetty ; 8 knight st; suite 201; norwalk 06851
• MDR Report Key: 19070273
• Report Number: 3004558433-2024-00001
• Device Sequence Number: 18897236
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 05/23/2025
• Device Model Number: BWENO1-B
• Device Lot Number: 317491, 320286
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• 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: 47 YR
• Patient Sex: Male