BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 18503909 · Received January 12, 2024

    Report

    Report Number
    3014226707-2023-02092
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 5, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    40851398007014
    PMA / PMN Number
    K233110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. FURTHER DISCUSSION WITH THE PATIENT REVEALED A PREDISPOSITION TO A BROAD SPECTRUM OF ALLERGENS, INCLUDING PROCLIVITY FOR ANAPHYLACTIC REACTIONS. THE PATIENT'S ACKNOWLEDGMENT OF POTENTIAL RISKS OUTLINED IN THE CAM® INSTRUCTIONS FOR USE, SPECIFICALLY REGARDING SKIN ALLERGIES, HAS BEEN DOCUMENTED. THE PATIENT DETERMINED THAT THE BENEFITS OF USING THE DEVICE TO INVESTIGATE THEIR CARDIAC SYMPTOMS JUSTIFY THE POTENTIAL FOR SUCH REACTIONS. THE SPECIFIC CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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 SUBMITTED COMPLAINT FILE: "PATIENT STARTED WEARING THE CAM ON 05-DEC-2023 AND CALLED (B)(6) ON 06-DEC-2023 AND COMPLAINED OF SKIN IRRITATION AND SHORTNESS OF BREATH. SHE HAD TO USE HER EPI PEN. SHE REMOVED THE CAM. THE PROVIDER DOES NOT WANT A NEW CAM PLACED." NOTE: FURTHER COMMUNICATION FOLLOW-UP DETERMINED THERE WAS NO SKIN IRRITATION. ALL OTHER INFORMATION FROM THE ORIGINAL COMPLAINT DESCRIPTION WAS VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057085 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 182454 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Required Intervention