BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHESIVE RING

    MDR report key: 23845865 · Received December 18, 2025

    Report

    Report Number
    3014226707-2025-00011
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 19, 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) DWG000911 LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTIONS AS POTENTIAL RISKS ASSOCIATED WITH USE. IN THIS CASE, THE PATIENT REPORTED DEVELOPING A WIDESPREAD RASH AFTER STARTING A NEW MEDICATION, BUPROPION, THE DAY FOLLOWING MONITOR APPLICATION. THE PATIENT AND THEIR PHYSICIAN ATTRIBUTED THE REACTION TO THE MEDICATION RATHER THAN THE MONITOR, AND THE PATIENT EXPRESSED CERTAINTY THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REACTION. THE RASH BEGAN ON THE LEGS, MIGRATED UPWARD, AND REACHED THE AREA WHERE THE MONITOR WAS PLACED BEFORE SPREADING TO THE COLLARBONE. THE PATIENT REMOVED THE MONITOR TO ALLOW TREATMENT, WHICH INCLUDED TOPICAL CREAMS AND ORAL PREDNISONE. 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: 3014226707-2025-00008).

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (B)(4): " PATIENT WROTE IN DIARY "DEVICE REMOVED DUE TO RASH."" ADDITIONAL INFORMATION: THE PATIENT REPORTED THAT THE RASH WAS DUE TO A DRUG REACTION. THEY BEGAN A NEW MEDICATION THE DAY AFTER STARTING THE MONITOR. THE PATIENT DESCRIBED ITCHY SPOTS INITIALLY APPEARING ON THE LEGS, THEN SPREADING UPWARD TO THE TORSO, REACHING THE AREA WHERE THE MONITOR WAS PLACED, AND EVENTUALLY EXTENDING TO THE COLLARBONE. THE PATIENT REMOVED THE MONITOR TO ALLOW TREATMENT OF THE REACTION. IT WAS LATER IDENTIFIED THAT THE ADHESIVE RING WAS USED IN ADDITION TO THE CAM DEVICE. CAM DEVICE MDR SUBMITTED UNDER MFR REPORT NUMBER: 3014226707-2025-00008 (ASSOCIATED WITH COMPLAINT (B)(4). FURTHER DETAILS: THE REACTION OCCURRED WHILE THE PATIENT WAS WEARING THE DEVICE. THE PATIENT TREATED THE RASH WITH CALAMINE AND MENTHOL CREAMS AVAILABLE AT HOME AND RECEIVED A PRESCRIPTION FOR ORAL PREDNISONE. THE PATIENT STATED THAT THE NEW MEDICATION, BUPROPION, CAUSED THE REACTION AND EXPRESSED CERTAINTY THAT THE MONITOR WAS NOT RESPONSIBLE. THE PATIENT INDICATED THAT THEIR PHYSICIAN AGREED WITH THIS ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238435 ADHESIVE RING MEDICAL ADHESIVE TAPE KGX BARDY DIAGNOSTICS, INC. AR250130 ST082025-1 0851398007

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Required Intervention CAM - HEART MONITORING DEVICE