BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENA

    MDR report key: 10445879 · Received August 24, 2020

    Report

    Report Number
    3011660924-2020-00008
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Report Date
    August 24, 2020
    Manufacturer
    LENA CUP LLC
    Product Code
    HHE
    UDI-DI
    00850008236143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT SINCE USING THE CUPS FROM (B)(6) 2019 AND ONWARDS THAT SHE HAS NOTICED HAVING ISSUES WITH CONSTANT UTI'S AFTER EVERY PERIOD THAT SHE USED THEM. SHE HAS HAD TO VISIT HER PHYSICIAN FOR ANTIBIOTICS. SHE HAS ALSO HAD ISSUES WITH THE CUP INSERTION AND NOT OPENING COMPLETELY ONCE INSERTED, AS WELL AS HAVING A LOT OF PRESSURE ON HER BLADDER, MAKING IT FEEL LIKE SHE CAN'T EMPTY HER BLADDER COMPLETELY WHEN THE CUP IS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909286 LENA MENSTRUAL CUP HHE LENA CUP LLC LENA-MIXII-2 00850008236143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other