MAUDE Adverse Event Report: BIOWAVE CORP. BIOWAVE; BIOWAVEHOME NEUROSTIMULATOR

Model Number	BWH-S
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bw findings: at 0% intensity, initial voltage was recorded at 6.4v and very unstable.Voltage outputs jumped from 3.2 to 15.04v, then after a minute voltage dropped to 0.3v and stayed steady for a minute.When the plus button was pressed, voltage jumped to approximately 19v then went all the way down to 0.2v.The intensity did not show as increasing.When plus button was pressed again, the unit reached 1.5% and then the automatic safety function triggered, and the intensity decreased.There was another attempt to increase the intensity, and the unit reached 7% when the auto safety function triggered and decreased the intensity.A third attempt to increase intensity got to 5% before the safety function triggered again.The unit would not go above 20v at any point.During testing, the treatment timer showed 29:45 despite no buttons being pressed.Lp cm findings: hairline fracture at r65 caused erratic power output.Sometimes unit would be at full power when first turned on.Other findings: the original production test sheets and aql sampling did not show voltage irregularities.Based on current findings, this appears to have occurred post-distribution.While the patient reported no known drops or trauma, misuse cannot be ruled out.There was no reported injury, but the malfunction could result in electric shock or burns in future use scenarios, especially for sensitive patients.Although the unit's internal safety mechanisms operated as intended to limit power output, this event represents a device malfunction that could potentially cause or contribute to serious injury if it recurred.
Event or Problem Description
The vets son called and informed she keeps getting shocked by unit.She gets shocked when turning on the unit.She just started using unit (b)(6) 2025.Now it keeps shocking her until she increases the intensity then it stops.No injury.She is cleaning skin with only water so far.She has got pain relief but concerned about the shocking feeling.

• Brand Name: BIOWAVE
• Common Device Name: BIOWAVEHOME NEUROSTIMULATOR
• Manufacturer (Section D): BIOWAVE CORP.; 8 knight st.; ste 201; norwalk CT 06851
• Manufacturer Contact: jarrett kycia ; 8 knight st; ste 201; norwalk, CT 06851
• MDR Report Key: 21938639
• Report Number: 3004558433-2025-00003
• Device Sequence Number: 14750549
• Product Code: GZJ
• UDI-Device Identifier: 00859911006072
• UDI-Public: 00859911006072
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BWH-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Patient Age: 88 YR
• Patient Sex: Female