BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENA CUP

    MDR report key: 10722923 · Received October 22, 2020

    Report

    Report Number
    3011660924-2020-00012
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    LENA CUP LLC
    Product Code
    HHE
    UDI-DI
    00850008236037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT SHE HAS EXPERIENCED URINARY TRACT INFECTIONS WITH THE CUP USE. SHE BELIEVES THAT WITH THE CUP IN PLACE SHE IS NOT ABLE TO EMPTY HER BLADDER, AND THIS CAUSED THE INFECTIONS. SHE HAS TAKEN ANTIBIOTICS EACH TIME TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185815 LENA CUP MENSTRUAL CUP HHE LENA CUP LLC LENA-GRN-L N/A 00850008236037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other