BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 23845642 · Received December 18, 2025

    Report

    Report Number
    3014226707-2025-00008
    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
    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 MSK6J-AFTA5 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 DEVICE DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. RECORDS INDICATE THAT APPROXIMATELY 12 DAY AND 20 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 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 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: 3014226707-2025-00011).

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (FROM (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. 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
    2423769 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 191387 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Required Intervention ADHESIVE RING MEDICAL ADHESIVE TAPE, (KGX).