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	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As written from the complaint (b)(4) description: "patient reported needing to take the cam off d/t skin irritation and blisters".Additional information: the patient stated they were given prednisone and oral antibiotic by the surgical center but was unable to provide the name of the antibiotic medication.The patient also stated they were given lidocaine at a surgical center.The patient mentioned blistering, oozing, and extreme itching.They stated that they went to a surgical center for care and were placed on prednisone and an antibiotic.The effect was isolated to the area of the patch which was the upper left breast of the patient.This is not the directed location of application per the cam instructions for use.The patient mentioned that it took 2 weeks for the irritation to subside.The device was requested to be returned on 20 sep 2024.At the time of this report, the device has not been obtained to perform an investigation or failure analysis.
Additional Manufacturer Narrative
The device history record (dhr) for unit x72tp-8gk97 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 to medical staff that they generally have sensitive skin.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.

• 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: 20314157
• Report Number: 3014226707-2024-01846
• Device Sequence Number: 18167626
• Product Code: DSH
• UDI-Device Identifier: 20851398007010
• UDI-Public: 20851398007010
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 12/27/2025
• Device Model Number: B7000
• Device Lot Number: 111623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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: 55 YR
• Patient Sex: Unknown