BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWITCHVIEW

    MDR report key: 15147784 · Received August 1, 2022

    Report

    Report Number
    MW5111221
    Event Type
    Injury
    Date Received
    August 1, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 29, 2022
    Manufacturer
    BLINK DEVICE COMPANY
    Product Code
    KOI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWITCHVIEW QUANTITATIVE TOF DEVICE HAS A STICKER/ELECTRODE THAT IS PLACED ON THE PATIENT'S HAND. UPON REMOVAL OF THE STICKER/ELECTRODE, THE PATIENT'S SKIN CAME OFF WITH THE STICKER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951559 TWITCHVIEW STIMULATOR, NERVE, PERIPHERAL, ELECTRIC KOI BLINK DEVICE COMPANY TVAEA025

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Disability