BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO TRANSCUTANEOUS KEGEL ELECTRICAL STIMULATOR

    MDR report key: 14471180 · Received May 20, 2022

    Report

    Report Number
    MW5109831
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    UNK
    Product Code
    QAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD AN EPISODE OF SUDDEN SYNCOPE WHEN USING THE INNOVO TRANSCUTANEOUS ELECTRICAL STIMULATION DEVICE (KEGEL EXERCISE). FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343588 INNOVO TRANSCUTANEOUS KEGEL ELECTRICAL STIMULATOR CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other