MAUDE Adverse Event Report: BIOWAVE CORPORATION BIOWAVEHOME NEUROSTIMULATION PAIN DEVICE; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Catalog Number	BWH-S
Health Effect - Clinical Codes	Erythema (1840); Electric Shock (2554); Blister (4537)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Individual reports that while using biowavehome unit on or around (b)(6) 2024, she attempted to run two consecutive sessions.Upon initiation of second session, she reports feeling a shock that caused a blister on her back.She reports using new electrodes.Redness was noted at time of report.Biowave unit was returned to vendor for inspection.

• Brand Name: BIOWAVEHOME NEUROSTIMULATION PAIN DEVICE
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): BIOWAVE CORPORATION; norwalk CT 06851
• MDR Report Key: 20002191
• Report Number: MW5158606
• Device Sequence Number: 4545821
• Product Code: GZJ
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: Health Professional
• Device Catalogue Number: BWH-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White