BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 21923224 · Received April 28, 2025

    Report

    Report Number
    3014226707-2025-00003
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 11, 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 WHSY5-6TBS1 CORRESPONDING TO COMPLAINT REFERENCE NUMBER (B)(4), HAS BEEN REVIEWED FOR COMPLIANCE WITH ESTABLISHED DEVICE MASTER RECORD (DMR). EXAMINATION DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY WITHIN THE DHR NOR ON DEVICE LABELING/PACKAGING THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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: "THE PATIENT LEFT A TYPED NOTE INSIDE THE BOX THAT STATES "ON THURSDAY (B)(6), I DID NOT HAVE ABNORMAL HEART SYMPTOMS BUT I DID NOTICEREDNESS AROUND THE DEVICE. BY FRIDAY, I STILL HAD NO HEART SYMPTOMS BUT THE REDNESS HAD BECOME MORE SEVERE. I WAS CONCERNED BECAUSE I HAD SUFFERED FROM ADHESIVE ALLERGIES IN THE PAST. IN ADDITION TO THE REDNESS AROUND THE DEVICE, BY SATURDAY THE AREA INCLUDED RASH TYPE BUMPS, ITCHING, BURNING, AND CLEAR LIQUID DRAINAGE. SINCE THE CONDITION WORSENED, I WAS SENT BY VA EMERGENCY TO COMMUNITY URGENT CARE. THE DESCRIBED MY CONDITION AS "CONTACT DERMATITIS". THEY REDRESSED THE AREA BUT BY THAT TIME THE DEVICE WAS TOO SATURATED TO STAY IN PLACE. NEW BANDAGES WERE APPLIED AND I WAS PRESCRIBED HYDROXYZ HCL 25 MG. I REMOVED THE NEW BANDAGE AND THE DEVICE FOR RETURN ON MONDAY (B)(6) WITHOUT EXPERIENCING ABNORMAL HEART OR CHEST SYMPTOMS SINCE THE ORIGINAL APPLICATION."" ADDITIONAL INFORMATION: THE DEVICE WAS RECIEVED FOR INVESTIGATION ON 09 APR 2025. FAILURE ANALYSIS CONCLUDED NO DEVICE NONCONFORMATIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326482 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 188442 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention