MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVE HOME

Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Hypoesthesia (2352)
Date of Event	12/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Improper use of device.The device is prescribed for her knew not for her arm.Treatment differs for different areas of body.She was trained for proper electrode placement on her knee not her arm.The device provided benefits for her knee.
Event or Problem Description
When patient turns on the device , unit is blinking and beeping and shocking at the same time pt wanted to press minus button or power button none of them worked so pt just peeled electrodes from arm.Injury occurred but patient did not seek any medical attention.Pt doesn't have any blisters, but pt couldn't move arm for 3 hours.In the follow up the patient mentioned that right arm isnt functioning properly, no damage to the skin but cant lift her arm over head or behind the back.
Event or Problem Description
When patient turns on the device , unit is blinking and beeping and shocking at the same time pt wanted to press minus button or power button none of them worked so pt just peeled electrodes from arm.Injury occurred but patient did not seek any medical attention.Pt doesn't have any blisters, but pt couldn't move arm for 3 hours.In the follow up the p[atient mentioned that righ arm isnt functioning properly, no damage to the skin but cant lift her arm over head or behind the back.
Additional Manufacturer Narrative
The root cause of the reported issue is not definitively clear as the device is not available for further investigation.However, based on the available details, the following observations and conclusions have been made.The patient did not seek medical attention following the incident.The device was prescribed for the patient's knee, not for use on the arm.The patient was trained solely on the proper knee electrode placements for the device.The patient received a wrap that is typically used with a conductive cream.It is conceivable that the patient placed noninvasive electrodes over the conductive cream on her skin.This action would have significantly dropped the impedance, resulting in the patient feeling a very small voltage spike upon turning on the device.It is important to note that a 1-volt spike would have been impossible to cause any harm or adverse event.If it had been a substantial shock, there would likely have been visible signs such as blisters or redness, but the patient reported none.Medical consultation: after consulting the treating doctor, it was confirmed that the device was solely prescribed for the patient's knee.The patient also confirmed that the device provided very positive benefits for her knee.The doctor mentioned that the patient was never instructed to use the device on her upper right extremity and was not taught the proper electrode placement for any upper right extremity pain the patient may have wanted to treat.Conclusion: based on the investigation, it appears that the incident may have resulted from the patient's incorrect use of the device outside the prescribed area (knee) and without proper training for such use.The significant drop in impedance caused by applying the conductive cream might have led to the patient feeling a minor voltage spike.However, there is no evidence to suggest that this could cause harm or an adverse event, as no physical symptoms such as blisters or redness were reported.

• Brand Name: BIOWAVE HOME
• Common Device Name: HOME
• 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: 19075352
• Report Number: 3004558433-2024-00004
• Device Sequence Number: 4658525
• Product Code: GZJ
• UDI-Device Identifier: 00859911006072
• UDI-Public: 0859911006072
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2023
• Supplement Date Received by Manufacturer: 12/02/2023
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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