BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENA

    MDR report key: 10589272 · Received September 25, 2020

    Report

    Report Number
    3011660924-2020-00010
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Report Date
    September 25, 2020
    Manufacturer
    LENA CUP LLC
    Product Code
    HHE
    UDI-DI
    00850008236006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP, AND HAD TO VISIT BOTH HER PRIMARY CARE PHYSICIAN AND HER GYNECOLOGIST TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053109 LENA MENSTRUAL CUP HHE LENA CUP LLC LENA-RED-S 00850008236006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other