MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. CAM System; Heart Monitoring Device

Model Number	B7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit kat29-1wsg5 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 device records determined no discrepancies or instances of non-conformity that could have caused or contributed to the reported event.The cam product instructions for use (ifu) lists skin irritation, allergic skin reactions and allergic symptoms as potential risks associated with device use.The ifu instructs patients to remove the cam immediately and contact their physician if irritation such as redness, severe itching, or allergic symptoms develop.
Event or Problem Description
Original complaint (from (b)(4)): "patient states the wore the cam for a couple of days then started to break out." additional information: the patient indicated that a medical professional prescribed unspecified steroid cream and antibiotics.

• 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: 50620115
• Report Number: 3014226707-2026-00011
• Device Sequence Number: 10525724
• 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): 09/04/2026

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: B7000
• Device Lot Number: 191392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown