BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SW-180

    MDR report key: 6412980 · Received March 17, 2017

    Report

    Report Number
    9614750-2017-00007
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    September 20, 2014
    Report Date
    March 17, 2017
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    IMJ
    PMA / PMN Number
    K022846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ITO EXAMINED THE DEVICE HISTORY RECORD FOR THE DEVICE INVOLVED IN THE ADVERSE EVENT. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. ONLY THE OSCILLATOR UNIT WAS RETURNED TO ITO. ITO CONDUCTED THE EVALUATION OF THE RETURNED OSCILLATOR UNIT BUT THERE WAS NO OUTPUT FROM THE UNIT. ITO RECEIVED A REPORT DESCRIBING MISUSE BY THE USER AND DOCUMENTED IT IN THE INVESTIGATION REPORT ON THE SUBJECT DEVICE (S/N (B)(4)). ITO REMINDED THE USER OF THE CORRECT USE OF THE DEVICE, AS DESCRIBED IN THE USER MANUAL.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN RECEIVING TREATMENT USING THE SUBJECT DEVICE WITH 40 W OUTPUT IN CONTINUOUS MODE. THE SUBJECT DEVICE BURNT THE PATIENT ON THE HIP DURING THE THIRTEENTH TREATMENT. ACCORDING TO THE HOSPITAL, THE BURN HAD FULLY HEALED BY (B)(6) 2014 WHEN ITO RECEIVED THE INFORMATION ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196503 SW-180 DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT IMJ ITO CO., LTD. TSUKUBA FACTORY SW-180

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other