BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 24228874 · Received January 30, 2026

    Report

    Report Number
    3014226707-2026-00001
    Event Type
    Injury
    Date Received
    January 30, 2026
    Report Date
    January 23, 2026
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    0851398007
    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 (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 OF DEVICE RECORDS DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTIONS AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. IN THIS CASE, THE PATIENT REPORTED THE SKIN THAT WAS IN CONTACT WITH THE DEVICE WAS "PEELING OFF" DURING DEVICE REMOVAL. THE PATIENT EXPRESSED THEY ARE ALLERGIC TO "ALL ADHESIVES" WHICH MAY BE A PRECONDITION TO THE EVENT. THE IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP.

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (FROM (B)(4)): "PATIENT STATES HE'S ALLERGIC TO ALL ADHESIVES. STATES THERE WAS NO OTHER SYMPTOMS OF THE SKIN BESIDES THE SKIN "PEELING OFF" WITH DEVICE REMOVAL. THE SKIN THAT WAS TOUCHING THE DEVICE ADHESIVE PEELED OFF WHEN REMOVING. PATIENT STATES HE GOT ANTIBIOTICS FOR THE WOUND CAUSED." ADDITIONAL INFORMATION: THE PATIENT LATER REPORTED THEY WERE PRESCRIBED "ORAL ANTIBIOTICS" TO TREAT THEIR WOUND. FURTHER DETAILS: THE PATIENT DESCRIBED THE SKIN REACTION TO BE LOCALIZED TO WHERE THE DEVICE WAS TOUCHING THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286957 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 195138 0851398007

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Required Intervention