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	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As written from the (b)(4) complaint description: patient wrote on diary "off at 6:48pm 6-26 due to hives".Additional information obtained from the patient regarding their skin irritation on (b)(6) 2025: please describe the skin reaction in detail: the patient said that the adhesive from the device caused her to break out in itchy hives that spread all over her body.Patient did reach out to her doctor and they prescribed her prednisone and betamethasone tablets which helped her skin and the hives slowly went away.It has happened before.She asked for paper tape at the doctor's office and they said no.Her skin has cleared up and is fine now.Additional information: the device was received for investigation on 30 jul 2025.Failure analysis was completed and no device nonconformance observed.
Additional Manufacturer Narrative
The device history record (dhr) for unit 1e6s1-5ymt3 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 determined no discrepancies or instances of non-conformity within the dhr that could have contributed to the reported event.Records indicate that approximately 2 days and 5 hours of viable data were able to be obtained from the device resulting in a successfully completed clinical report.The cam product instructions for use (ifu) lists skin irritation and allergic skin reaction as potential risks associated with device use.The ifu states to remove the cam immediately and to contact their physician if irritation such as redness, severe itching or allergic symptoms develop.As noted by the patient, the patient removed the device after 2 days due to hives developing all over their body.The patient noted that symptoms improved after taking prescribed medication(s).This report has been compiled in accordance with the mandatory reporting requirements set forth under 21 cfr part 803 for serious injuries.The submission of this report is not to be construed as an acknowledgement by bardy diagnostics of any defect or malfunction in the product described herein.

• 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: 22745079
• Report Number: 3014226707-2025-00004
• Device Sequence Number: 17962681
• 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): 08/07/2025

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: 01/23/2026
• Device Model Number: B1400
• Device Lot Number: 039870
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown