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	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient left a note in the box stating woke up with [generalized] itchy rash." additional information provided by the patient: (25 nov 2025) she does not believe it was from monitor because she noticed it the day, she was scheduled to remove the device and it was not localized too the monitor placement.The rash spread.She said it was on her back, legs and stomach.The patient went to a prompt care and was prescribed oral prednisone.The patient stated she only took it for 2 days because it was causing pvcs (premature ventricular contractions).The patient also used vaseline on her skin to help with itching.Additional details: the patient stated multiple times she did not believe the monitor to be the cause of the rash, but was uncertain what did cause it.There is still a slight imprint of the cam on the patient's chest, but it is going away.The patient did not mention that an adhesive ring was used, however it was noticed when the device was returned for failure analysis that an adhesive ring was attached to the device.
Additional Manufacturer Narrative
The device history record (dhr) for unit 8zmfv-ew572 corresponding to complaint reference number (b)(4), has been reviewed for compliance with established device master record (dmr).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 13 day and 17 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.The patient reported that the practice applied an unknown cream during device application to facilitate easier removal, which is not part of the cam ifu.The patient stated that the irritation was localized only to the areas where the cream was applied and expressed confidence that the cream caused the reaction.The ifu instructs patients to remove the cam immediately and contact their physician if irritation such as redness, severe itching, or allergic symptoms develop.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.References: complaint (b)(4) (adhesive ring mdr submitted) mdr (3500a form) submitted on (b)(6) 2025 for adhesive ring.Mfr report number: 3014226707-2025-00007.

• 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: 23835438
• Report Number: 3014226707-2025-00006
• Device Sequence Number: 9267656
• 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: 190889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown