BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 19939218 · Received August 8, 2024

    Report

    Report Number
    3014226707-2024-01552
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    20851398007010
    PMA / PMN Number
    K233110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY WITHIN THE DHR THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT MENTIONED THAT THEY HAVE EXPERIENCED MINOR ADHESIVE REACTIONS IN THE PAST. IT IS EVIDENT THAT THE PATIENT DOES HAVE A PREDISPOSITION TO MATERIAL(S) FOUND WITHIN THE PATIENT ADHESIVE. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION AND ALLERGIC SKIN REACTION AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. 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.

    Description of Event or Problem · 0

    AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PER PATIENTS DIARY: "TOOK OFF - SEVERE IRRITATION" PER PATIENTS EMAIL: "I HAD A SEVERE ALLERGIC REACTION THAT LEFT WHAT LOOKED LIKE A CHEMICAL BURN THAT BLISTERED THE WHOLE LENGTH OF WHERE THE MONITOR WAS ADHERRED ON MY CHEST AND HAD TO BE TREATED BY MY PRIMARY CARE FOR A BURN. IT WAS VERY PAINFUL FOR TWO WEEKS AND I STILL CAN SEE THE MARK." ADDITIONAL INFORMATION: THE PRIMARY CARE DOCTOR TREATED THE PATIENT WITH TOPICAL STEROID CREAM AND "BURN CREAM" AND SUGGESTED THE PATIENT NOT USE THIS TYPE OF ADHESIVE ANYMORE. THE MEDICATION USED WAS: PREDNISONE 10 MG ORAL TABLETS & SILVADENE CREAM (TOPICAL TREATMENT). SKIN PREP WAS LIMITED TO ALCOHOL WIPES PROVIDED BY THE PRODUCT KIT. IT TOOK APPROXIMATELY TWO WEEKS FOR THE REACTION TO HEAL OVER, HOWEVER THERE WAS STILL A VISIBLE MARK AS OF (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069343 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B7000 102923 20851398007010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention| O