BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EU-940

    MDR report key: 6261109 · Received January 18, 2017

    Report

    Report Number
    9614750-2017-00004
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    June 20, 2016
    Report Date
    January 18, 2017
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    GZJ
    PMA / PMN Number
    K071137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS EXAMINED FOR THE SUBJECT EU-940 DEVICE. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. UPON RECEIPT OF THE SUBJECT DEVICE, ITO CONDUCTED EVALUATION OF THE FAILURE ANALYSIS OF THE RETURNED DEVICE. INSPECTION OF THE RETURNED DEVICE: MEASUREMENT OF OUTPUT VOLTAGE: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF OUTPUT ELECTRIC CURRENT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF PULSE WIDTH: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF FREQUENCY: WITHIN THE PRE-DEFINED SPECIFICATIONS. CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULT: THE SUBJECT DEVICE FUNCTIONS WITHOUT ANY ABNORMALITY. ITO REMINDED THE USER OF THE CORRECT USAGES, AS DESCRIBED IN THE USER MANUAL. THE HEALTHCARE FACILITY DID NOT DISCLOSE THE INFORMATION ON THE PATIENT'S AGE AND WEIGHT.

    Description of Event or Problem · 1

    A PATIENT WAS TREATED FOR WHIPLASH FROM A TRAFFIC ACCIDENT ON THE RIGHT SIDE OF HIS NECK. THE TREATMENT WAS ADMINISTERED AT HIGH VOLTAGE WITH AN OUTPUT OF 60-70 VOLTS, A FREQUENCY OF 4-10 HERTZ, AND A PULSE WIDTH OF 20 MICRON SECONDS, FOR 10 MINUTES. A RASH AND BURN DEVELOPED ON THE RIGHT SIDE OF THE PATIENT'S NECK ON THE NEXT DAY OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42892 EU-940 STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF GZJ ITO CO., LTD. TSUKUBA FACTORY EU-940

    Patients

    Seq Age Sex Outcome Treatment
    1 Other