BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 14112346 · Received April 14, 2022

    Report

    Report Number
    1317188-2022-00008
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 14, 2022
    Manufacturer
    MEDICO ELECTRODES INTERNATIONAL LTD
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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. AS A LOT NUMBER WAS NOT PROVIDED, A REVIEW OF LOT RECORD PAPERWORK CANNOT BE COMPLETED.

    Description of Event or Problem · 0

    PATIENT COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL STATING THAT THERE WAS BLISTERING, TEARING, AND ITCHINIG OF THE SKIN FROM THE DEVICE ELECTRODES. THE PHYSICIAN PRESCRIBED A STEROID CREAM .5% TO APPLY TO THE AFFECTED AREA. THE PATIENT WAS OFFERED ALTERNATIVE SENSITIVE SKIN ELECTRODES FOR MONITORING PERIOD COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639292 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other