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

Model Number BWENO1-B

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 09/29/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 339702600
• Report Number: 3004558433-2024-00001
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: BWENO1-B
• Device Lot Number: 317491, 320286
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• 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: 47 YR
• Patient Sex: Male