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	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit msk6j-afta5 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 device determined no discrepancies or instances of non-conformity that could have caused or contributed to the reported event.Records indicate that approximately 12 day and 20 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 developing a widespread rash after starting a new medication, bupropion, the day following monitor application.The patient and their physician attributed the reaction to the medication rather than the monitor, and the patient expressed certainty that the device did not cause or contribute to the reaction.The rash began on the legs, migrated upward, and reached the area where the monitor was placed before spreading to the collarbone.The patient removed the monitor to allow treatment, which included topical creams and oral prednisone.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: 3014226707-2025-00011).
Event or Problem Description
Original complaint (from (b)(4)): " patient wrote in diary "device removed due to rash"".Additional information: the patient reported that the rash was due to a drug reaction.They began a new medication the day after starting the monitor.The patient described itchy spots initially appearing on the legs, then spreading upward to the torso, reaching the area where the monitor was placed, and eventually extending to the collarbone.The patient removed the monitor to allow treatment of the reaction.Further details: the reaction occurred while the patient was wearing the device.The patient treated the rash with calamine and menthol creams available at home and received a prescription for oral prednisone.The patient stated that the new medication, bupropion, caused the reaction and expressed certainty that the monitor was not responsible.The patient indicated that their physician agreed with this assessment.

• 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: 23845642
• Report Number: 3014226707-2025-00008
• Device Sequence Number: 10030123
• 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: 191387
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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: 84 YR
• Patient Sex: Unknown