MAUDE Adverse Event Report: BIOWAVE CORP. BIOWAVE CORP.; SILVER BIOWRAPS

Model Number	BWRPSILVER-BACK-SM
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was confirmed to be functioning as designed.No manufacturing anomalies were identified review of the current quick reference guide (qrg, rev 5) confirms that the labeling specifically directs patients to apply biowave theracream conductive cream as the sole conductive medium prior to device use.Theracream is referenced consistently throughout the directions for use and troubleshooting sections, and is included in the product package.However, the qrg does not contain an explicit warning against the use of alternative topical products, sprays, or creams in conjunction with the device.The contraindications section does not address the use of non-indicated topical substances.As a result, while theracream use was specified, the hazard of using alternative topical products was not adequately communicated to patients or clinicians, and was not identified as a risk in the device risk management file.Planned corrective actions:1.Update ifu to include explicit warnings against use of topical sprays, lotions, or creams in conjunction with the device2.Update risk management file to include identified hazard and associated risk controls3.Issue communication to clinicians regarding contraindication.
Event or Problem Description
Patient reported development of blisters on skin following use of biowrap silver back, an electrode garment wrap.Prior to use, patient applied a topical spray (cigna spray ) to the skin, which was recommended by their treating clinician.Patient developed blisters at the site of device contact.

• Brand Name: BIOWAVE CORP.
• Common Device Name: SILVER BIOWRAPS
• Manufacturer (Section D): BIOWAVE CORP.; 19 newtown turnpike; westport CT 06880
• Manufacturer Contact: jarrett kycia ; 19 newtown turnpike; westport, CT 06880 ; 2032434890
• MDR Report Key: 24680018
• Report Number: 3004558433-2026-00001
• Device Sequence Number: 9652761
• Product Code: GXY
• UDI-Device Identifier: 00859911006232
• UDI-Public: 00859911006232
• 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: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Device Model Number: BWRPSILVER-BACK-SM
• Device Lot Number: 033180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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: 65 YR
• Patient Sex: Male