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

Model Number BWENO1-B

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Blister (4537)

Event Date 08/23/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 339706245
• Report Number: 3004558433-2024-00002
• 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: Other
• 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 Expiration Date: 07/29/2022
• Device Model Number: BWENO1-B
• Device Lot Number: 119354
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 43 YR
• Patient Sex: Female