BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOVI SCANNER

    MDR report key: 7826616 · Received August 29, 2018

    Report

    Report Number
    3014545134-2018-00106
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    November 23, 2017
    Report Date
    August 27, 2018
    Manufacturer
    ITOVI
    Product Code
    GZO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    0000000-06/08/18-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER ESTABLISHMENT: ITOVI (B)(4). CLASSIFICATION NAME: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT PRODUCT CODE: GZO. DEVICE CLASS: 2. (B)(4). MEDICAL SPECIALTY: NEUROLOGY. REGISTERED ESTABLISHMENT NAME: ITOVI. OWNER/OPERATOR: ITOVI. (B)(4). ESTABLISHMENT OPERATIONS: MANUFACTURER. COMPLAINT FILE ESTABLISHMENT FOR SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER ESTABLISHMENT: HUDSON SCIENTIFIC LLC. (B)(4) STATUS: ACTIVE. *NOTE FIRM MAY HAVE ADDITIONAL ESTABLISHMENT TYPES. PLEASE REVIEW LISTINGS FOR FURTHER INFORMATION. DATE OF REGISTRATION STATUS: 2018. OWNER/OPERATOR: HUDSON SCIENTIFIC LLC (B)(4). ESTABLISHMENT OPERATIONS: COMPLAINT FILE ESTABLISHMENT. SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER IS IN THE PROCESS OF REDESIGNING A NEW MEDICAL DEVICE FOR SUBSEQUENT REPLACEMENT.

    Description of Event or Problem · 1

    (B)(6) RECEIVED EMAIL ON THE 31ST DAY OF JULY, 2018: CUSTOMER SAYS GRANDDAUGHTER WAS SHOCKED. CUSTOMER REPORT ROUTED TO (B)(4). (B)(4) RESPONDED TO CUSTOMER AND CUSTOMER REPEATED THAT GRANDDAUGHTER WAS SHOCKED LAST (B)(4). CUSTOMER REPORT ROUTED TO (B)(4). (B)(4) RECEIVED AN EMAIL ON THE 7TH DAY OF AUGUST, 2018 ASKING FOR A REFUND BECAUSE OF SHOCK TO GRANDDAUGHTER. (B)(4) RESPONDED TO CUSTOMER ON THE 17TH DAY OF AUGUST TO INFORM HER THAT ITOVI HAS OPENED AN INVESTIGATION INTO THE ACCOUNT AND WOULD NOT BE ABLE TO GIVE A REFUND AT THIS TIME. AGREED TO STAY IN TOUCH TO RESOLVE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666929 ITOVI SCANNER ITOVI SCANNER GZO ITOVI ITS15 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR