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)
Type of Reportable Event	Serious Injury
Event or Problem Description
As written from the complaint (b)(4) description: "patient wrote a diary entry on (b)(6) 2024 stating, "removed device due to rash"." additional information: the patient stated that they removed the device after 12 days from developing the rash and indicated that the irritation spread beyond where the device was applied.The patient sought treatment and was prescribed oral prednisone and benadryl.The patient indicated that the irritation has since improved since taking the prescribed medication.The device was requested to be returned on 06 jan 2025 and delivered to the manufacturer on 09 jan 2025.There has been no indication of a device non-conformance.It was found that an unknown adhesive film (not bardydx recommended tegaderm) was applied over the device.
Additional Manufacturer Narrative
The device history record (dhr) for unit kwnfz-htur6 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 15 days of viable data were able to be obtained from the device resulting in a successfully completed clinical report.It was found that an unknown adhesive film (not bardydx recommended tegaderm) was applied over the device.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, they continued to where the device for 12 days after developing a rash.The patient noted that symptoms improved after taking prescribed medication.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: 21260899
• Report Number: 3014226707-2025-00002
• Device Sequence Number: 9494328
• 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): 01/27/2025

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: 05/18/2025
• Device Model Number: B1400
• Device Lot Number: 184183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (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: 80 YR
• Patient Sex: Unknown