BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOVI SCANNER

    MDR report key: 7826614 · Received August 29, 2018

    Report

    Report Number
    3014545134-2018-00105
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 10, 2018
    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

    ON THE (B)(4) 2018 (B)(4) RECEIVED A CUSTOMER EMAIL; CUSTOMER EMAILED ITOVI REQUESTING THE RECALL FORM, BUT ALSO MENTIONED THAT ON OF HER CLIENTS WERE SHOCKED BY THE DEVICE. EMAIL ROUTED TO (B)(4). ON THE (B)(4) 2018 (B)(4) RECEIVED A CUSTOMER EMAIL; CUSTOMER CLAIMS A TEENAGER THAT THEY SCANNED WAS SHOCKED TWICE, BUT THAT SHE DIDN'T THINK MUCH OF IT. EMAIL ROUTED TO (B)(4). SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER: ESTABLISHMENT: (B)(4). CLASSIFICATION NAME: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT, PRODUCT CODE: GZO, DEVICE CLASS: 2, REGULATION NUMBER: (B)(4), MEDICAL SPECIALTY: NEUROLOGY, REGISTERED ESTABLISHMENT NAME: ITOVI. (B)(4) . ESTABLISHMENT OPERATIONS: MANUFACTURER. COMPLAINT FILE ESTABLISHMENT FOR SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER (B)(4). STATUS: ACTIVE. NOTE FIRM MAY HAVE ADDITIONAL ESTABLISHMENT TYPES. PLEASE REVIEW LISTINGS FOR FURTHER INFORMATION. DATE OF REGISTRATION STATUS: 2018. (B)(4). 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

    ON THE (B)(4) 2018 (B)(4) RECEIVED A CUSTOMER EMAIL; CUSTOMER EMAILED ITOVI REQUESTING THE RECALL FORM, BUT ALSO MENTIONED THAT ONE OF HER CLIENTS WERE SHOCKED BY THE DEVICE. EMAIL ROUTED TO (B)(4). ON THE (B)(4) 2018 (B)(4) RECEIVED A CUSTOMER EMAIL; CUSTOMER CLAIMS A TEENAGER THAT THEY SCANNED WAS SHOCKED TWICE, BUT THAT SHE DIDN'T THINK MUCH OF IT. EMAIL ROUTED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666927 ITOVI SCANNER ITOVI GZO ITOVI ITS15 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR