MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE NONINVASIVE ELECTRODES; NON INVASIVE ELECTRODES

Model Number	BWENO1-B
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Wife has been using her husband's unit for the past 1 1/2 to treat leg pain focused in her right hamstring.Never has had any issues unit yesterday.Later in the day after the treatment, she felt burning/itching and noticed a pus-filled blister near the area or possible under the area where one of the electrodes had been placed on her upper hamstring/glut area.No issue under the other pad which had been placed 6" apart on her lower hamstring.
Additional Manufacturer Narrative
As the electrodes were not available to evaluate it is not possible to determine the root cause.However the most likely cause is that wire from one electrode might have pulled partially out of the electrodes contacting skin causing a blister.When a patient sits on the electrodes it is possible the leadwire cable can pull on the electrode wire.Another important point to be notes is that these electrodes were expired.

• Brand Name: BIOWAVE NONINVASIVE ELECTRODES
• Common Device Name: NON INVASIVE 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: 19070505
• Report Number: 3004558433-2024-00002
• Device Sequence Number: 15188047
• Product Code: GXY
• UDI-Device Identifier: 00859911006089
• UDI-Public: 0859911006089
• 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: Other
• 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: 07/29/2022
• Device Model Number: BWENO1-B
• Device Lot Number: 119354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 43 YR
• Patient Sex: Female