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
Additional Manufacturer Narrative
The device history record (dhr) for unit nkhe1-9pdn3 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 and allergic skin reactions 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): "the pt states the device caused him to turn red/ he states he is allergic to nickel." additional information: the patient reported a known allergy to nickel and stated that use of the device resulted in skin reactions including redness, burning, and itching.The patient further reported that the reaction spread across the chest and abdomen.The patient sought medical attention in the emergency room, where he reported receiving an unspecified injection, as well as treatment with hydroxyzine and naproxen.Additional attempts were made to identify the injected medication; however, these efforts were unsuccessful.Prior complaint (b)(4) involved the same cam id and institution.Two attempts were made at that time to obtain additional information about the reaction and treatment with no response.No additional information was obtained at that time.

• 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: 25492484
• Report Number: 3014226707-2026-00004
• Device Sequence Number: 15882082
• 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): 06/12/2026

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 Expiration Date: 02/06/2026
• Device Model Number: B1400
• Device Lot Number: 190889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 52 YR
• Patient Sex: Unknown