BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 17414071 · Received July 28, 2023

    Report

    Report Number
    1317188-2023-00009
    Event Type
    Injury
    Date Received
    July 28, 2023
    Report Date
    July 28, 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

    NO LOT NUMBER OR SAMPLES WERE PROVIDE SO NO DHR REVIEW OR THOROUGH INVESTIGATION COULD BE COMPLETED. A REVIEW OF THE BIOCOMPATABILITY REPORT STATES PATIENT INTERACTING MATERIALS ARE NON-CYTOTOXIC, NON-SENSITIZING, AND NON-IRRITATING.

    Description of Event or Problem · 0

    PATIENT REPORTED EXPERIENCING SEVERE SKIN IRRITATION WHILE WEARING THE PATCH ATTACHED TO THE BLACK LEAD OF THE LWA. PATIENT MENTIONED BURNING SENSATION, SCARRING AND RAISED LYMPH NODES. PATIENT REPORTED THAT THE COLLAR BONE TO ARMPITS WERE SWOLLEN. PATIENT ALSO HAD PAIN IN THE SHOULDER TO ELBOW AND FROM BACK OF THE ARMPIT AREA. PATIENT STATED THE BLACK LEAD WAS HOTTER THAN NORMAL TO THE TOUCH. PATIENT REPORTED THAT THE ELECTRODE ATTACHED TO THE BLACK LEAD WAS MELTED AND THE DEVICE WAS NOT BEING CHARGED. PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS GIVEN ANTIBIOTICS. THE DEVICE WAS NOT ACCIDENTLY DAMAGE DURING USAGE. PATIENT HAS NO IMPLANTABLE DEVICES. PATIENT STATES NO SKIN IRRITATION OR ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326708 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention