BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 22745079 · Received August 7, 2025

    Report

    Report Number
    3014226707-2025-00004
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 7, 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 1E6S1-5YMT3 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 2 DAYS AND 5 HOURS 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 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, THE PATIENT REMOVED THE DEVICE AFTER 2 DAYS DUE TO HIVES DEVELOPING ALL OVER THEIR BODY. THE PATIENT NOTED THAT SYMPTOMS IMPROVED AFTER TAKING PRESCRIBED MEDICATION(S). 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 (B)(4) COMPLAINT DESCRIPTION: PATIENT WROTE ON DIARY "OFF AT 6:48PM 6-26 DUE TO HIVES". ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT REGARDING THEIR SKIN IRRITATION ON (B)(6) 2025: PLEASE DESCRIBE THE SKIN REACTION IN DETAIL: THE PATIENT SAID THAT THE ADHESIVE FROM THE DEVICE CAUSED HER TO BREAK OUT IN ITCHY HIVES THAT SPREAD ALL OVER HER BODY. PATIENT DID REACH OUT TO HER DOCTOR AND THEY PRESCRIBED HER PREDNISONE AND BETAMETHASONE TABLETS WHICH HELPED HER SKIN AND THE HIVES SLOWLY WENT AWAY. IT HAS HAPPENED BEFORE. SHE ASKED FOR PAPER TAPE AT THE DOCTOR'S OFFICE AND THEY SAID NO. HER SKIN HAS CLEARED UP AND IS FINE NOW. ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR INVESTIGATION ON 30 JUL 2025. FAILURE ANALYSIS WAS COMPLETED AND NO DEVICE NONCONFORMANCE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433954 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 039870 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Required Intervention