BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 23845749 · Received December 18, 2025

    Report

    Report Number
    3014226707-2025-00009
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 17, 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 T6A3F-MYN76 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 BOTH THE RECORDS AND THE DEVICES DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. RECORDS INDICATE THAT APPROXIMATELY 9 DAYS AND 23 HOURS OF VIABLE DATA WAS OBTAINED FROM THE DEVICE RESULTING IN A SUCCESSFULLY COMPLETED CLINICAL REPORT. 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 AN ITCHY, RED RASH UNDER THE RING ADHESIVE DURING DEVICE WEAR AND LATER DEVELOPED SHINGLES CONFIRMED BY A PHYSICIAN. THE PATIENT EXPRESSED UNCERTAINTY WHETHER THE SHINGLES WERE RELATED TO THE ADHESIVE REACTION OR COINCIDENTAL. THE IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP. REFERENCES: COMPLAINT (B)(4) (ADHESIVE RING MDR SUBMITTED, MFR REPORT NUMBER: 3014226707-2025-00010)

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (FROM (B)(4): "PATIENT WROTE IN DIARY, "REMOVED/ADHESIVE DISCOMFORT"" ADDITIONAL INFORMATION: THE PATIENT REPORTED DEVELOPING AN ITCHY, RED RASH UNDER THE RING ADHESIVE PLACED OVER THE DEVICE. TWO DAYS AFTER REMOVING THE MONITOR, THE PATIENT EXPERIENCED A SHINGLES OUTBREAK CONFIRMED BY A PHYSICIAN. THE SHINGLES APPEARED ON THE PATIENT'S BACK AND SIDE AND SPREAD TO THE LEFT BREAST. THE PATIENT STATED THEY HAVE AN ADHESIVE ALLERGY BUT HAD NEVER EXPERIENCED SHINGLES BEFORE. THEY WERE UNSURE WHETHER THE SHINGLES WERE TRIGGERED BY THE ADHESIVE REACTION OR OCCURRED COINCIDENTALLY. FURTHER DETAILS: THE RASH OCCURRED WHILE THE PATIENT WAS WEARING THE DEVICE AND WAS LOCALIZED UNDER THE RING ADHESIVE. THE PATIENT SOUGHT TREATMENT AND WAS PRESCRIBED ORAL ANTIVIRAL MEDICATION (ZALTREX), WHICH THEY REPORTED WAS HELPING. THE PATIENT DESCRIBED THE SKIN REACTION AS ITCHY AND RED, WITH THE RASH SPREADING BEYOND THE ADHESIVE SITE AFTER MONITOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242166 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 193231 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Required Intervention ADHESIVE RING MEDICAL ADHESIVE TAPE, (KGX)