BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NISSHA MEDICAL TECHNOLOGIES

    MDR report key: 15537159 · Received October 4, 2022

    Report

    Report Number
    1317188-2022-00014
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    November 22, 2021
    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. A LOT NUMBER COULD NOT BE PROVIDED SO A DHR REVIEW COULD NOT BE CONDUCTED. SINCE THE END CUSTOMER (BIOTEL HEART DISTRIBUTOR) REPORTED THE COMPLAINT, NISSHA MEDICAL TECHNOLOGIES, THE IMPORTER IS ALSO REPORTING THE INCIDENT.

    Description of Event or Problem · 0

    PATIENT REPORTED SEVERE REACTION TO THE GEL FROM THE PATCH. STATES PATIENT BASELINE 11/2 PATIENT WAS WEARING THE PATCH BUT THEN STARTED HAVING SYMPTOMS OF ANAPHYLACTIC SHOCK. PATIENT WAS ALSO EXPERIENCING SHORTNESS OF BREATH, BRUISING AND SKIN IRRITATION WITH BLEEDING FROM THE PATCH SITE. PATIENT CONSULTED A CLINICIAN AND WAS GIVEN STEROIDS FOR MEDICAL TREATMENT. PATIENT IS IMPROVING. BIOTEL HEART DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION FROM THEIR FDA SUBMISSION REPORT. THIS IS WHAT THEY PROVIDED: SHE IS CURRENTLY FEELING BETTER BUT WILL BE REMOVING THE DEVICE AND SENDING BACK. SHE WILL CONSULT WITH HER DOCTOR FIRST BEFORE DECIDING TO CONTINUE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387315 NISSHA MEDICAL TECHNOLOGIES ECG MONITORING ELECTRODE DRX MEDICO ELECTRODES INTERNATIONAL LTD A10091-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other