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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myalgia (2238)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device retrieval has been initiated.Root cause investigation is pending physical inspection of the returned unit.Preliminary engineering assessment identifies possible solder joint failure in the output amplifier section as a potential hardware failure mechanism.This hypothesis remains unconfirmed pending device inspection.This report is submitted based on malfunction indicators present in the complaint record independent of confirmed root cause determination, consistent with 21 cfr 803.16.Biowave corporation will submit a follow-up mdr report upon completion of device inspection and root cause investigation, or within the timeframe required by 21 cfr 803.50, whichever occurs first.
Event or Problem Description
A veteran patient was using the biowavehome for treatment at the bilateral lateral cervical muscles (c6/c7) at her usual intensity of 12-16%.The patient was lying down and not moving during treatment.Skin preparation was performed using a baby wipe prior to electrode placement.Upon turning the device on, the display showed an abnormal readout of "7 minutes." the device then delivered an unintended electrical output of sufficient magnitude to physically displace the patient from a lying position.The patient's husband was present and was required to physically disconnect the lead wire from the unit to terminate therapy, as the power button was non-functional.Following the event, the device display showed a blue screen and the unit could not be powered off via the power button.The patient reported being very sore the following day.No medical attention was sought.No visible injury or skin marks were observed.

• Brand Name: BIOWAVE CORPORATION
• Common Device Name: BIOWAVEHOME
• Manufacturer (Section D): BIOWAVE CORP.; 19 newtown turnpike; westport CT 06880 1802
• Manufacturer Contact: jarrett kycia ; 19 newtown turnpike; westport, CT 06880-1802 ; 8772469283
• MDR Report Key: 25600033
• Report Number: 3004558433-2026-00002
• Device Sequence Number: 9922564
• 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: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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: 44 YR
• Patient Sex: Female