BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHESIVE RING

    MDR report key: 23835449 · Received December 17, 2025

    Report

    Report Number
    3014226707-2025-00007
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 10, 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 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. THE ADHESIVE RING INSTRUCTIONS FOR USE (IFU) DWG000911 LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTIONS AS POTENTIAL RISKS ASSOCIATED WITH USE. PLEASE REFERENCE COMPLAINT (B)(4), (30593) FOR THE COMPLETED FAILURE ANALYSIS AND RESULTS. ADDITIONAL REFERENCES: COMPLAINT (B)(4), (CAM DEVICE MDR SUBMITTED) MDR (3500A FORM) SUBMITTED ON 17 DEC 2025 FOR CAM DEVICE. MFR REPORT NUMBER: 3014226707-2025-00006.

    Description of Event or Problem · 0

    PATIENT LEFT A NOTE IN THE BOX STATING WOKE UP WITH [GENERALIZED] ITCHY RASH." ADDITIONAL INFORMATION PROVIDED BY THE PATIENT: ((B)(6) 2025) SHE DOES NOT BELIEVE IT WAS FROM MONITOR BECAUSE SHE NOTICED IT THE DAY, SHE WAS SCHEDULED TO REMOVE THE DEVICE AND IT WAS NOT LOCALIZED TO THE MONITOR PLACEMENT. THE RASH SPREAD. SHE SAID IT WAS ON HER BACK, LEGS AND STOMACH. THE PATIENT WENT TO A PROMPT CARE AND WAS PRESCRIBED ORAL PREDNISONE. THE PATIENT STATED SHE ONLY TOOK IT FOR 2 DAYS BECAUSE IT WAS CAUSING PVCS (PREMATURE VENTRICULAR CONTRACTIONS). THE PATIENT ALSO USED VASELINE ON HER SKIN TO HELP WITH ITCHING. ADDITIONAL DETAILS: THE PATIENT STATED MULTIPLE TIMES SHE DID NOT BELIEVE THE MONITOR TO BE THE CAUSE OF THE RASH, BUT WAS UNCERTAIN WHAT DID CAUSE IT. THERE IS STILL A SLIGHT IMPRINT OF THE CAM ON THE PATIENT'S CHEST BUT IT IS GOING AWAY. THE PATIENT DID NOT STATE AN ADHESIVE RING WAS USED; HOWEVER, IT WAS NOTICED WHEN THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS THAT AN ADHESIVE RING WAS ATTACHED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016653 ADHESIVE RING MEDICAL ADHESIVE TAPE KGX BARDY DIAGNOSTICS, INC ST082025-1 0851398007

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention CAM SYSTEM - HEART MONITORING DEVICE