BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOVI TRACKER

    MDR report key: 7670538 · Received July 9, 2018

    Report

    Report Number
    3014545134-2018-00102
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 10, 2018
    Manufacturer
    ITOVI
    Product Code
    GZO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    0000000-06/08/18-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER: ESTABLISHMENT: ITOVI (B)(4). STATUS: ACTIVE; AWAITING ASSIGNMENT OF REGISTRATION NUMBER. DATE OF REGISTRATION STATUS: 2018. OWNER/OPERATOR: ITOVI (B)(4). PROPRIETARY NAME: ITOVI. CLASSIFICATION NAME: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT. PRODUCT CODE: GZO. DEVICE CLASS: 2. REGULATION NUMBER: (B)(4). MEDICAL SPECIALTY: NEUROLOGY. REGISTERED ESTABLISHMENT NAME: ITOVI. OWNER/OPERATOR: ITOVI. OWNER/OPERATOR NUMBER: (B)(4). ESTABLISHMENT OPERATIONS: MANUFACTURER. COMPLAINT FILE ESTABLISHMENT FOR IVOVI: (B)(4). STATUS: ACTIVE. INITIAL DISTRIBUTOR/IMPORTER: NO. NOTE FIRM MAY HAVE ADDITIONAL ESTABLISHMENT TYPES. PLEASE REVIEW LISTINGS FOR FURTHER INFORMATION. DATE OF REGISTRATION STATUS: 2018. OWNER/OPERATOR: (B)(4). OWNER/OPERATOR NUMBER: (B)(4). OFFICIAL CORRESPONDENT: (B)(4).

    Description of Event or Problem · 1

    VIA AN E-MAIL TO THE FINISHED PRODUCT MANUFACTURER/ SPECIFICATION DEVELOPER ON (B)(6) 2018, THE COMPLAINANT REPORTED THAT ON/AROUND (B)(6) 2018, HE RECEIVED A BLOOD BLISTER WHEN USING THE ITOVI DEVICE (I.E. WHILE SCANNING AND UNPLUGGED FROM A POWER SOURCE). THE FINISHED PRODUCT MANUFACTURER/ SPECIFICATION DEVELOPER REQUESTED THE UNIT TO BE RETURNED BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511943 ITOVI TRACKER GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO GZO ITOVI ITS10 032016

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR