BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 14042276 · Received April 7, 2022

    Report

    Report Number
    1317188-2022-00006
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 5, 2022
    Manufacturer
    MEDICO ELECTRODES INTERNATIONAL LTD
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT CONSULTED A CLINICIAN AND COMPLAINED THAT THE DEVICE ELECTRODES WERE MAKING HIS SKIN BUMPY AND BLOODY. THE PHYSICIAN PRESCRIBED HYDROCORTISONE OINTMENT TO APPLY TO THE AFFECTED AREA. THE PATIENT DECIDED TO RETURN THE ACTUAL DEVICE EARLY AND DID NOT CONTINUE ENROLLMENT. THE PATIENT DID NOT RETURN ELECTRODES. THE PATIENT DID ADVISE THEY HAVE SENSITIVE SKIN. HE ELECTRODE PART NUMBER IS 32028476, A10091-30 AND THE LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841949 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other