BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHESIVE RING

    MDR report key: 23845662 · Received December 18, 2025

    Report

    Report Number
    3014226707-2025-00010
    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
    KGX
    UDI-DI
    0851398007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADHESIVE RING INSTRUCTIONS FOR USE (IFU) (B)(4) LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTIONS AS POTENTIAL RISKS ASSOCIATED WITH USE. IN THIS CASE, THE PATIENT REPORTED AN ITCHY, RED RASH UNDER THE RING ADHESIVE DURING 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 DEVICE HISTORY RECORD (DHR) FOR ADHESIVE RING LOT ST082025-1 WAS REVIEWED FOR COMPLIANCE WITH THE ESTABLISHED DEVICE MASTER RECORD (DMR), INCLUDING CERTIFICATES OF CONFORMANCE FOR PATIENT-CONTACT MATERIALS. EXAMINATION OF THIS RECORD DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REFERENCES: COMPLAINT (B)(4) (CAM DEVICE MDR SUBMITTED, MFR REPORT NUMBER: 3014226707-2025-00009).

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (B)(4). "PATIENT WROTE IN DIARY, "REMOVED/ADHESIVE DISCOMFORT"". COMPLAINT SUMMARY FOR ADHESIVE RING (ASSOCIATED WITH (B)(4). PATIENT REPORTED ADHESIVE DISCOMFORT WHILE WEARING THE CAM MONITOR AND ADHESIVE RING. THE PATIENT DEVELOPED AN ITCHY, RED RASH LOCALIZED UNDER THE RING ADHESIVE DURING DEVICE WEAR. 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. ADDITIONAL INFORMATION: · RASH OCCURRED WHILE THE PATIENT WAS WEARING THE CAM DEVICE AND ADHESIVE RING, LOCALIZED UNDER THE RING ADHESIVE. · PATIENT SOUGHT TREATMENT AND WAS PRESCRIBED ORAL ANTIVIRAL MEDICATION (ZALTREX), WHICH THEY REPORTED WAS HELPING. · SKIN REACTION DESCRIBED AS ITCHY AND RED, WITH RASH SPREADING BEYOND THE ADHESIVE SITE AFTER MONITOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258751 ADHESIVE RING MEDICAL ADHESIVE TAPE KGX BARDY DIAGNOSTICS, INC. AR250130 ST082025-1 0851398007

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Required Intervention CAM - HEART MONITORING DEVICE