BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVA PELVIC HEALTH SYSTEM

    MDR report key: 18949527 · Received March 20, 2024

    Report

    Report Number
    MW5153034
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    March 17, 2024
    Report Date
    March 20, 2024
    Manufacturer
    AXENA HEALTH, INC.
    Product Code
    HIR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE REPORTER CALLED REGARDING LEVA PELVIC HEALTH SYSTEM. THE REPORTER MENTIONED HAVING ABDOMINAL CRAMPS WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317381 LEVA PELVIC HEALTH SYSTEM PERINEOMETER HIR AXENA HEALTH, INC. LEVA-02

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other