BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENA

    MDR report key: 10590079 · Received September 25, 2020

    Report

    Report Number
    3011660924-2020-00011
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Report Date
    September 25, 2020
    Manufacturer
    LENA CUP LLC
    Product Code
    HHE
    UDI-DI
    00850008236068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    USER REPORTED THAT SHE HAD PAIN WHEN USING THE CUP AND HAS NOTICED A MODERATE INCREASE IN HER CYSTOCELE.

    Description of Event or Problem · 1

    USER REPORTED THAT SHE HAD PAIN WHEN USING THE CUP AND HAS NOTICED A MODERATE INCREASE IN HER CYSTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050906 LENA MENSTRUAL CUP HHE LENA CUP LLC LENA-PUR-L 161039 00850008236068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other