BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN, APEX

    MDR report key: 10836622 · Received November 12, 2020

    Report

    Report Number
    MW5097830
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 9, 2020
    Manufacturer
    INCONTROL MEDICAL, LLC
    Product Code
    KPI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTING FALSE LABELING BY INCONTROL MEDICAL. THEY KEEP ADVERTISING A CURE AND A LIFELONG CURE FOR INCONTINENCE. THEY HAVE BEEN DOING THIS FOR YEARS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298864 ATTAIN, APEX STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE KPI INCONTROL MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1