BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 15537158 · Received October 4, 2022

    Report

    Report Number
    1317188-2022-00012
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 4, 2022
    Manufacturer
    MEDICO ELECTRODES INTERNATIONAL LTD
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICO WAS EMAILED FOR THEIR BIOCOMPATIBILITY REPORT. THE RESULTS OF THE GEL AND ADHESIVE (THOSE WHICH HAVE DIRECT CONTACT WITH SKIN) WERE BOTH FOUND TO BE NON-CYTOTOXIC, NON-SENSITIZING, AND NON-IRRITATING. MEDICO ALSO STATES THEY USED APPROVED SUPPLIERS THAT FOLLOW STANDARDIZED QMS AND ALL RAW MATERIALS ARE INSPECTED WHEN RECEIVED IN. MEDICO HAS STATED THAT AFTER REVIEW OF THEIR RAW MATERIAL AND PRODUCTION RECORDS, THERE WERE NO CHANGES TO THE COMPOSITION OF THE RAW MATERIALS AND NO CHANGES IN PRODUCTION. A TREND REPORT SHOWS THERE HAS NOT BEEN A SIGNIFICANT INCREASE IN SKIN REACTION COMPLAINTS OVER THE PAST 3 YEARS AND THE ELECTRODES ARE SOLD WORLDWIDE. THE IFU (ON THE POUCH) STATES THE ELECTRODES ARE HYPOALLERGENIC AND AN ELECTRODE IS ONLY TO BE WORN FOR LESS THAN 72 HOURS. SINCE A LOT NUMBER COULD NOT BE PROVIDED, A DHR REVIEW COULD NOT BE PERFORMED. NO FURTHER ACTION WILL BE TAKEN. SINCE THE END CUSTOMER REPORTED THE COMPLAINT, (B)(4), THE IMPORTER IS ALSO REPORTING THE INCIDENT.

    Description of Event or Problem · 0

    PATIENT REPORTED WAS DIAGNOSED WITH MRSA SKIN INFECTION, AND WAS PRESCRIBED ANTIBIOTICS BY A CLINICIAN. THE PATIENT WAS WEARING THE DEVICE LESS THAN A WEEK BEFORE MRSA INFECTION APPEARED. STATES MD TOLD PATIENT HE EITHER GOT MRSA FROM THE MCOT PATCH OR LWA. IRRITATION TO THE ENTIRE ELECTRODE AREA. MANUFACTURER OF THE LWA DEVICE RECEIVED THE DEVICE BACK BUT DUE TO THE PACKAGING POTENTIALLY BEING IN CONTACT WITH MRSA, THE PACKAGE COULD NOT BE OPENED AND WAS DISPOSED OF DUE TO LOCAL BIOHAZARD LAWS. THE INVESTIGATION FROM THE MANUFACTURER OF THE LWA DEVICE IS BELOW: THERE IS NO ALLEGATION OR EVIDENCE OF A DEVICE MALFUNCTION. IT WAS IDENTIFIED THAT THE PATIENT WAS USING THE LEAD WIRE ADAPTER (LWA) WHICH UTILIZED A 3RD PARTY MANUFACTURED ELECTRODE. THIS IS THE ACCESSORY THAT MAKES CONTINUOUS CONTACT WITH THE PATIENT AND IS LIKELY THE CAUSE OF THE SKIN IRRITATION. BRAEMAR DEVICES ARE NOT KNOWN TO CAUSE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). IT HAS BEEN CONFIRMED THAT THE PATIENT DID NOT FOLLOW INSTRUCTED SKIN CARE PREPARATION/REGIMENT BEFORE PLACING THE ELECTRODE ON THEIR SKIN. BIOTEL HEART DISTRIBUTION FOLLOWS PROCEDURE FOR CLEANING BEFORE BEING SHIPPED TO PATIENTS. MARSI, SKIN BURN, AND ASSOCIATED SYMPTOMS MAY INHERENTLY OCCUR UNDER THE COURSE OF ECG MONITORING. NO SINGLE FACTOR OR COMBINATION OF FACTORS CAN BE ATTRIBUTABLE TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PRODUCT LABELING ADVISES PATIENTS OF ALTERNATE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED. MEDICAL TREATMENT: ANTIBIOTICS PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387314 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other