BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 17714292 · Received September 8, 2023

    Report

    Report Number
    1317188-2023-00010
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 8, 2023
    Manufacturer
    MEDICO ELECTRODES INTERNATIONAL LTD
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS COMPLETED WITH NO NOTED NONCONFORMANCES. THERE HAVE BEEN NO ALTERATIONS IN RAW MATERIALS USED FOR PRODUCTION. BIOCOMPATIBILITY REPORT STATES THE SKIN CONTACTING MATERIALS ARE NON-CYTOTOXIC, NON-SENSITIZING AND NON-IRRITATING. SAMPLES WERE NOT RETURNED FOR EVALUATION. NO FURTHER INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS MINOR PEELING OF THE SKIN FROM THE ELECTRODE. ORIGINALLY THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND FOLLOWED THE SKIN PREP OF SOAP, WATER AND DRYING WITH A CLOTH. THE PATIENT PAUSED SERVICE AND FLEX WAS ORDER. A FEW DAYS LATER THE PATIENT REPORTED THAT THEIR SKIN WAS RED, INFLAMED AND ITCHY. THE PATIENT HAD A RASH ON TORSO AND WAS MONITORING. THE PATIENT STARTED TAKING BENADRYL AND RECEIVED THE CLOTH ELECTRODES. THE PATIENT WAS LATER PRESCRIBED A Z PACK AND STEROIDS PILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113605 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 48322V13

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other