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	Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit (b)(6) 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.The patient mentioned that they have experienced minor adhesive reactions in the past.It is evident that the patient does have a predisposition to material(s) found within the patient adhesive.The cam product instructions for use (ifu) lists skin irritation and allergic skin reaction as potential risks associated with device use.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.
Event or Problem Description
As written from the complaint (b)(4) description: "per patients diary: "took off - severe irritation" per patients email: "i had a severe allergic reaction that left what looked like a chemical burn that blistered the whole length of where the monitor was adherred on my chest and had to be treated by my primary care for a burn.It was very painful for two weeks and i still can see the mark." additional information: the primary care doctor treated the patient with topical steroid cream and "burn cream" and suggested the patient not use this type of adhesive anymore.The medication used was: prednisone 10 mg oral tablets & silvadene cream (topical treatment).Skin prep was limited to alcohol wipes provided by the product kit.It took approximately two weeks for the reaction to heal over, however there was still a visible mark as of (b)(6) 2024.

• 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; WA
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98005
• MDR Report Key: 19939218
• Report Number: 3014226707-2024-01552
• Device Sequence Number: 7413924
• Product Code: DSH
• UDI-Device Identifier: 20851398007010
• UDI-Public: 20851398007010
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/06/2024

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: 10/24/2025
• Device Model Number: B7000
• Device Lot Number: 102923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Unknown