MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. CAM SYSTEM; HEART MONITORING DEVICE

Model Number	B1400
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 device history record (dhr) for unit t6a3f-myn76 corresponding to complaint reference number (b)(4), has been reviewed for compliance with established device master record (dmr), including certificates of conformance for patient contact materials.Examination of both the records and the devices determined no discrepancies or instances of non-conformity that could have caused or contributed to the reported event.Records indicate that approximately 9 days and 23 hours of viable data was obtained from the device resulting in a successfully completed clinical report.The cam product instructions for use (ifu) lists skin irritation and allergic skin reactions as potential risks associated with device use.In this case, the patient reported an itchy, red rash under the ring adhesive during device 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 ifu instructs patients to remove the cam immediately and contact their physician if irritation such as redness, severe itching, or allergic symptoms develop.References: complaint (b)(4) (adhesive ring mdr submitted, mfr report number: 3014226707-2025-00010).
Event or Problem Description
Original complaint (from (b)(4): "patient wrote in diary, "removed/adhesive discomfort"" additional information: the patient reported developing an itchy, red rash under the ring adhesive placed over the device.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.Further details: the rash occurred while the patient was wearing the device and was localized under the ring adhesive.The patient sought treatment and was prescribed oral antiviral medication (zaltrex), which they reported was helping.The patient described the skin reaction as itchy and red, with the rash spreading beyond the adhesive site after monitor removal.

• Brand Name: CAM SYSTEM
• Common Device Name: HEART MONITORING DEVICE
• Manufacturer (Section D): BARDY DIAGNOSTICS, INC.; 220 120th avenue ne; suite 100; bellevue WA 98005
• Manufacturer (Section G): QUALITEL CORPORATION
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98005
• MDR Report Key: 23845749
• Report Number: 3014226707-2025-00009
• Device Sequence Number: 9958164
• Product Code: DSH
• UDI-Device Identifier: 40851398007014
• UDI-Public: 40851398007014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233110
• 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 Expiration Date: 02/06/2026
• Device Model Number: B1400
• Device Lot Number: 193231
• 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: 06/02/2024
• 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: ADHESIVE RING MEDICAL ADHESIVE TAPE, (KGX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown