BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 24656439 · Received March 20, 2026

    Report

    Report Number
    3014226707-2026-00002
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    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 (B)(6) 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 DEVICE RECORDS DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. RECORDS INDICATE THAT APPROXIMATELY 13 DAYS AND 3 HOURS OF ANALYSIS TIME 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 IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP.

    Description of Event or Problem · 0

    ORIGINAL COMPLAINT (FROM (B)(4): "PARENT OF PT CALLED TO REPORT THAT THEIR CHILD HAD A SEVERE REACTION TO THE ADHESIVE OF THE MONITOR. THEY DESCRIBED IT AS AN ITCHY RED RASH THAT HAD FORMED BLISTERS THAT SPREAD AND REQUIRED MEDICAL INTERVENTION". ADDITIONAL INFORMATION: THE PATIENT LATER REPORTED THAT THE REACTION EXPANDED TO APPROXIMATELY THREE TIMES THE SIZE OF THE CAM AT THE DEVICE PLACEMENT SITE. THEY STATED THAT THEY WERE PRESCRIBED MEDICATION TO TREAT A POTENTIAL INFECTION; HOWEVER, THE SPECIFIC PRESCRIPTION COULD NOT BE OBTAINED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717411 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 190064

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Required Intervention