MAUDE Adverse Event Report: BIOWAVE CORP BIOWAVE; SILVER BIOWRAPS

Model Number	BWRP-SILVER-THIGH-CALF
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Burn occurred on monday, 4/14.User was using thigh/calf wrap on arm.Clinician had set user up for treatment with unit on his lap.She left and when she came back to check on user, she saw unit was on 100% intensity.User had turned intensity all the way up and treatment immediately ended.Burns were noticed afterward.
Additional Manufacturer Narrative
The burn incident occurred because the user did not follow device usage instructions.The patient used a thigh/calf wrap on the arm, which is outside the intended use described in the instructions for use (ifu).Additionally, the patient manually increased the intensity to 100%, exceeding the recommended maximum intensity of 50% for proprioception therapy patients as clearly stated in the ifu.Although the treatment was initiated under clinician supervision, it appears that either the patient neglected the provider's instructions or the clinician failed to adequately monitor the patient during the session.The incident occurred in a clinical setting; however, the patient, who resides in an assisted living facility, had been previously trained along with the facility staff.The device has not yet been returned for evaluation to fully rule out a malfunction.However, given the facts, inappropriate wrap usage, excessive intensity setting, and patient self-adjustment, user misuse is the most probable root cause, rather than device malfunction.

• Brand Name: BIOWAVE
• Common Device Name: SILVER BIOWRAPS
• 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: 21938645
• Report Number: 3004558433-2025-00004
• Device Sequence Number: 5192632
• Product Code: GXY
• UDI-Device Identifier: 00859911006546
• UDI-Public: 00859911006546
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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 Model Number: BWRP-SILVER-THIGH-CALF
• Device Lot Number: 110701
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 05/07/2022
• 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: 74 YR
• Patient Sex: Male