BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 21064148 · Received January 2, 2025

    Report

    Report Number
    3014226707-2024-02508
    Event Type
    Injury
    Date Received
    January 2, 2025
    Report Date
    January 2, 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 09XEM-1ZXK0 CORRESPONDING TO COMPLAINT REFERENCE NUMBER 24-2508, 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 9 DAYS OF VIABLE DATA WERE ABLE TO BE OBTAINED FROM THE DEVICE RESULTING IN A SUCCESSFULLY COMPLETED CLINICAL REPORT. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTION AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. THE IFU ALSO STATES TO REMOVE THE CAM IMMEDIATELY AND TO CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING OR ALLERGIC SYMPTOMS DEVELOP. THE PHYSICIAN INSTRUCTED THE PATIENT TO REMOVE THE TEGADERM ADHESIVE AND CONTINUE THE WEAR STUDY SUBSEQUENT TO THE PATIENT'S INITIAL SKIN REACTION. IT WAS CONFIRMED THAT THE PATIENT'S SKIN IRRITATION DID IMPROVE. ALSO, THE PATIENT WAS REGISTERED APPROXIMATELY TWO DAYS PRIOR TO THE DEVICE'S EXPIRATION DATE OF 22 NOV 2024. 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: "NOTE INCLUDED IN THE BOX SAYS, "RED, BURNING, ITCHY SKIN UNDER TEGADERM HOLDING THE HOLTER MONITOR". " ADDITIONAL INFORMATION: THE PATIENT'S MOTHER NOTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE MONITOR AND BROKE OUT IN BLISTERS. IT WAS NOTED THAT THE IRRITATION WAS LOCALIZED TO THE SURROUNDING AREA OF THE DEVICE AND THE TEGADERM ADHESIVE; IRRITATION DID NOT GO BEYOND THE TEGADERM. THE PATIENT DID SEEK TREATMENT FOR THE SKIN IRRITATION AND WAS LATER PRESCRIBED VISTARIL THAT WAS TAKEN ORALLY. THE PROVIDER INSTRUCTED THE USER TO REMOVE JUST THE TEGADERM AND CONTINUE THE WEAR STUDY. THE PATIENT THEN REMOVED THE DEVICE AFTER FOUR ADDITIONAL DAYS. ON (B)(6) 2024, THE PATIENT'S MOTHER COMMUNICATED THAT THE SKIN IRRITATION HAD IMPROVED. THE DEVICE WAS REQUESTED TO BE RETURNED ON 18 DEC 2024 AND DELIVERED TO THE MANUFACTURER ON 26 DEC 2024. THERE HAS BEEN NO INDICATION OF A DEVICE NON-CONFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434098 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 182456 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown Required Intervention