BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 25193530 · Received May 15, 2026

    Report

    Report Number
    3014226707-2026-00003
    Event Type
    Injury
    Date Received
    May 15, 2026
    Report Date
    March 20, 2026
    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 (B)(6) CORRESPONDING TO COMPLAINT REFERENCE NUMBER (B)(4) AND MDR REPORT KEY 24656439 WAS REVIEWED FOR COMPLIANCE WITH THE ESTABLISHED DEVICE MASTER RECORD (DMR), INCLUDING CERTIFICATES OF CONFORMANCE FOR PATIENT CONTACT MATERIALS. NO DISCREPANCIES OR INSTANCES OF NONCONFORMANCE WERE IDENTIFIED 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 INITIAL REPORT DESCRIBED A DERMATOLOGIC REACTION AT THE DEVICE PLACEMENT SITE, INCLUDING RASH, BLISTERING, AND SPREAD, WITH AN INDICATION THAT PRESCRIPTION MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 7-MAY-2026 CONFIRMED THAT THE PATIENT WAS TREATED WITH OVER-THE-COUNTER MEDICATIONS, SPECIFICALLY TOPICAL HYDROCORTISONE AND ORAL CETIRIZINE (ZYRTEC), WITH NO PRESCRIPTION MEDICATIONS ADMINISTERED. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) IDENTIFIES SKIN IRRITATION AND ALLERGIC REACTIONS AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE AND INSTRUCTS PATIENTS TO REMOVE THE DEVICE AND CONTACT A PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS OCCUR.

    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" ON (B)(6) 2026, A COMPLAINT WAS RECEIVED REPORTING THAT A PEDIATRIC PATIENT EXPERIENCED A DERMATOLOGIC REACTION AT THE SITE OF MONITOR ADHESIVE APPLICATION, DESCRIBED AS AN ITCHY RED RASH WITH BLISTERING THAT SPREAD TO APPROXIMATELY THREE TIMES THE SIZE OF THE DEVICE PLACEMENT AREA. MEDICAL EVALUATION WAS SOUGHT, AND IT WAS INITIALLY REPORTED THAT PRESCRIPTION MEDICATION WAS PROVIDED TO TREAT A POTENTIAL INFECTION; HOWEVER, SPECIFIC MEDICATION DETAILS COULD NOT BE OBTAINED PRIOR TO MDR SUBMISSION ON 20-MAR-2026. ADDITIONAL INFORMATION RECEIVED ON 7-MAY-2026 CONFIRMED THE PATIENT WAS TREATED WITH OVER-THE-COUNTER MEDICATIONS, SPECIFICALLY TOPICAL HYDROCORTISONE AND CETIRIZINE (ZYRTEC), WITH NO PRESCRIPTION MEDICATIONS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109564 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 190064 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Other