BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 21260899 · Received January 28, 2025

    Report

    Report Number
    3014226707-2025-00002
    Event Type
    Injury
    Date Received
    January 28, 2025
    Report Date
    January 27, 2025
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    40851398007014
    PMA / PMN Number
    K233110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR UNIT KWNFZ-HTUR6 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. RECORDS INDICATE THAT APPROXIMATELY 15 DAYS OF VIABLE DATA WERE ABLE TO BE OBTAINED FROM THE DEVICE RESULTING IN A SUCCESSFULLY COMPLETED CLINICAL REPORT. IT WAS FOUND THAT AN UNKNOWN ADHESIVE FILM (NOT BARDYDX RECOMMENDED TEGADERM) WAS APPLIED OVER THE DEVICE. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTION AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. THE IFU STATES TO REMOVE THE CAM IMMEDIATELY AND TO CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING OR ALLERGIC SYMPTOMS DEVELOP. AS NOTED BY THE PATIENT, THEY CONTINUED TO WHERE THE DEVICE FOR 12 DAYS AFTER DEVELOPING A RASH. THE PATIENT NOTED THAT SYMPTOMS IMPROVED AFTER TAKING PRESCRIBED MEDICATION. 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.

    Description of Event or Problem · 0

    AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PATIENT WROTE A DIARY ENTRY ON (B)(6) 2024 STATING, "REMOVED DEVICE DUE TO RASH"." ADDITIONAL INFORMATION: THE PATIENT STATED THAT THEY REMOVED THE DEVICE AFTER 12 DAYS FROM DEVELOPING THE RASH AND INDICATED THAT THE IRRITATION SPREAD BEYOND WHERE THE DEVICE WAS APPLIED. THE PATIENT SOUGHT TREATMENT AND WAS PRESCRIBED ORAL PREDNISONE AND BENADRYL. THE PATIENT INDICATED THAT THE IRRITATION HAS SINCE IMPROVED SINCE TAKING THE PRESCRIBED MEDICATION. THE DEVICE WAS REQUESTED TO BE RETURNED ON 06 JAN 2025 AND DELIVERED TO THE MANUFACTURER ON 09 JAN 2025. THERE HAS BEEN NO INDICATION OF A DEVICE NON-CONFORMANCE. IT WAS FOUND THAT AN UNKNOWN ADHESIVE FILM (NOT BARDYDX RECOMMENDED TEGADERM) WAS APPLIED OVER THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792415 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 184183 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention