BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 23835438 · Received December 17, 2025

    Report

    Report Number
    3014226707-2025-00006
    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
    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 8ZMFV-EW572 CORRESPONDING TO COMPLAINT REFERENCE NUMBER (B)(4), HAS BEEN REVIEWED FOR COMPLIANCE WITH ESTABLISHED DEVICE MASTER RECORD (DMR).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 13 DAY AND 17 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. THE PATIENT REPORTED THAT THE PRACTICE APPLIED AN UNKNOWN CREAM DURING DEVICE APPLICATION TO FACILITATE EASIER REMOVAL, WHICH IS NOT PART OF THE CAM IFU. THE PATIENT STATED THAT THE IRRITATION WAS LOCALIZED ONLY TO THE AREAS WHERE THE CREAM WAS APPLIED AND EXPRESSED CONFIDENCE THAT THE CREAM CAUSED THE REACTION. THE IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP. THIS REPORT HAS BEEN COMPILED IN ACCORDANCE WITH THE MANDATORY REPORTING REQUIREMENTS SET FORTH UNDER 21 CFR PART 803 FOR SERIOUS INJURIES. THE SUBMISSION OF THIS REPORT IS NOT TO BE CONSTRUED AS AN ACKNOWLEDGEMENT BY BARDY DIAGNOSTICS OF ANY DEFECT OR MALFUNCTION IN THE PRODUCT DESCRIBED HEREIN. REFERENCES: COMPLAINT (B)(4) (ADHESIVE RING MDR SUBMITTED) MDR (3500A FORM) SUBMITTED ON (B)(6) 2025 FOR ADHESIVE RING. MFR REPORT NUMBER: 3014226707-2025-00007.

    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: (25 NOV 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 TOO 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 MENTION THAT 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
    2015724 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC B1400 190889 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention ADHESIVE RING