Lena LENA-MIXII-1Recalls & reported problems
Lena Cup, LLC · A reusable menstrual cup that collects monthly blood flow. Lena 2-Pack Purple and Turquoise · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850008236129), received between Nov 8, 2020 and Nov 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Fungal Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
USER REPORTED THAT SHE EXPERIENCED ITCHINESS DURING CUP USE AND HER DOCTOR PRESCRIBED MEDICATION FOR YEAST INFECTION AND THE SYMPTOMS SUBSIDED. SHE HAD INITIALLY USED DIAL ANTIBACTERIAL SOAP FOR CLEANING THE CUP, BUT EVEN AFTER BOILING ONLY WITH WATER, SHE AGAIN EXPERIENCED THE SAME SYMPTOMS AND THEREFORE DECIDED TO DISCONTINUE USE.
Patient problems: Fungal Infection
MAUDE report 10806560 ↗
Other Cup, Menstrual devices
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- Flex Cup and Flex Disc Flex Discovery Kit Slim FitThe Flex Company · Cup, Menstrual6 reports
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- Lena LENA-PUR-SLena Cup, LLC · Cup, Menstrual6 reports
- Lena LENA-RED-SLena Cup, LLC · Cup, Menstrual5 reports
- Cora 10MENSTRUALCUP-S1DTCCora · Cup, Menstrual5 reports
- Lena LENA-MIXII-2Lena Cup, LLC · Cup, Menstrual5 reports
- Flex Cup and Flex Disc Flex Discovery Kit Full FitThe Flex Company · Cup, Menstrual4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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