MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. ADHESIVE RING; MEDICAL ADHESIVE TAPE

Model Number	AR250130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adhesive ring instructions for use (ifu) (b)(4) lists skin irritation and allergic skin reactions as potential risks associated with use.In this case, the patient reported an itchy, red rash under the ring adhesive during wear and later developed shingles confirmed by a physician.The patient expressed uncertainty whether the shingles were related to the adhesive reaction or coincidental.The device history record (dhr) for adhesive ring lot st082025-1 was reviewed for compliance with the established device master record (dmr), including certificates of conformance for patient-contact materials.Examination of this record determined no discrepancies or instances of non-conformity that could have caused or contributed to the reported event.References: complaint (b)(4) (cam device mdr submitted, mfr report number: 3014226707-2025-00009).
Event or Problem Description
Original complaint (b)(4)."patient wrote in diary, "removed/adhesive discomfort"".Complaint summary for adhesive ring (associated with (b)(4).Patient reported adhesive discomfort while wearing the cam monitor and adhesive ring.The patient developed an itchy, red rash localized under the ring adhesive during device wear.Two days after removing the monitor, the patient experienced a shingles outbreak confirmed by a physician.The shingles appeared on the patient's back and side and spread to the left breast.The patient stated they have an adhesive allergy but had never experienced shingles before.They were unsure whether the shingles were triggered by the adhesive reaction or occurred coincidentally.Additional information: · rash occurred while the patient was wearing the cam device and adhesive ring, localized under the ring adhesive.· patient sought treatment and was prescribed oral antiviral medication (zaltrex), which they reported was helping.· skin reaction described as itchy and red, with rash spreading beyond the adhesive site after monitor removal.

• Brand Name: ADHESIVE RING
• Common Device Name: MEDICAL ADHESIVE TAPE
• Manufacturer (Section D): BARDY DIAGNOSTICS, INC.; 220 120th avenue ne; suite 100; bellevue WA 98005
• Manufacturer (Section G): THE STROUSE CORPORATION
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98005
• MDR Report Key: 23845662
• Report Number: 3014226707-2025-00010
• Device Sequence Number: 15845848
• Product Code: KGX
• UDI-Device Identifier: 0851398007
• UDI-Public: 0851398007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: AR250130
• Device Lot Number: ST082025-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAM - HEART MONITORING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown