BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 18049284 · Received November 1, 2023

    Report

    Report Number
    1317188-2023-00012
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    August 25, 2023
    Report Date
    November 1, 2023
    Manufacturer
    MEDICO ELECTRODES INTERNATIONAL LTD
    Product Code
    DRX
    UDI-DI
    10009336008343
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED WITH NO FINDINGS OR NOTED NONCONFORMANCES WHILE MAKING THE LOT NUMBER IN QUESTION. BIOCOMPATIBILITY REPORTS HAVE BEEN COMPLETED FOR SKIN CONTACTING COMPONENTS WITH PASSING RESULTS AND ARE DETERMINED TO BE NON-CYTOTOXIC, NON-SENSITIZING, AND NON IRRTATING. SAMPLES WERE NOT AVAILABLE FOR RETURN AND NO FURTHER INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THEY WERE EXPERIENCING SEVERE SKIN BURNS WHILE USING HE C6 SENSOR WITH FLEX ADAPTOR. THE PATIENT STATED THEY HAD LUMPS AND BURNS FROM THE METAL ATTACHMENT. THE PATIENT FOLLOWED THE RECOMMENDED SKIN PREP. PATIENT REPORTED THAT THEY ARE NO LONGER WANTING TO CONTINUE WITH SERVICE. THE PATIENT USED SULFADIAZINE CREAM ON THE SEVERE SKIN BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032892 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 25322V13 10009336008343

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other