BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 20846909 · Received December 4, 2024

    Report

    Report Number
    3014226707-2024-02270
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    20851398007010
    PMA / PMN Number
    K233110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 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.

    Description of Event or Problem · 0

    AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PATIENT EXPERIENCED IRRITATION AND BURNING WHILE WEARING THE DEVICE. WENT TO URGENT CARE AND WAS PRESCRIBED MEDICATION" ADDITIONAL INFORMATION: THE PATIENT INDICATED THAT THE IRRITATION SPREAD BETWEEN THE COLLARBONE DOWN TO THE STOMACH. THE PATIENT INDICATED THAT THEY VISITED A MEDICAL PROFESSIONAL THAT PRESCRIBED ORAL PREDNISONE DAILY FOR A 5-DAY PERIOD. BARDY DIAGNOSTICS WAS MADE AWARE THAT THE PATIENT'S IRRITATION WAS "NO LONGER RED" FOLLOWING THEIR TREATMENT. THE DEVICE WAS REQUESTED TO BE RETURNED ON 13 NOV 2024. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN OBTAINED TO PERFORM AN INVESTIGATION OR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850535 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B7000 188069 20851398007010

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Required Intervention