The DivaCup Model 2Recalls & reported problems
Diva International Inc · Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857538000022), received between Jun 25, 2019 and Jun 25, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Pain1
- Anemia1
- Diarrhea1
- Fever1
- Purulent Discharge1
- Renal Failure1
- Tachycardia1
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE INITIAL REPORTER OF THE EVENT TO HEALTH (B)(6) ((B)(6) 2019) AND CONFIRMED BY (B)(6) (MAY 29, 2019): (B)(6) BEGAN EXPERIENCING SYMPTOMS (FEVER) ON (B)(6) 2019 TOWARDS THE END OF HER MENSTRUAL CYCLE. THE PATIENT CONTINUED TO WEAR THE DIVACUP (MODEL 2), EMPTYING AND CLEANING THE DEVICE EVERY 6 HOURS. THE PATIENT REMOVED THE DIVACUP THE FOLLOWING DAY ON (B)(6) 2019 (AROUND 2PM) AT THE END OF HER MENSTRUAL CYCLE (SHE HAD WORN THE CUP FOR 7 DAYS, EMPTYING AND CLEANING EVERY 6 HOURS). AT THIS TIME, THE PATIENT REPORTED SLIGHT STOMACH PAIN, HER ABDOMEN WAS PINK AND HARD, AND CONTINUING FEVER. THE PATIENT SUBSEQUENTLY EXPERIENCED VOMITING, DIARRHEA AND HIGH FEVER. THE PATIENT CALLED AN AMBULANCE ON (B)(6) 2019 AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH TOXIC SHOCK SYNDROME (TSS). ANTIBIOTICS WERE STARTED EARLY AND SHE WAS ADMITTED TO CRITICAL CARE IN CRITICAL CONDITION REQUIRING INTRAVENOUS FLUID RESUSCITATION, 3 SIMULTANEOUS VASOPRESSOR AGENTS AND ENDOTRACHEAL INTUBATION. THE INITIAL EXAMINATION SHOWED SIGNIFICANT ABDOMINAL PAIN AS WELL AS PAIN IN THE CERVIX AND APPENDAGES. COMPUTED TOMOGRAPHY REVEALED SIGNS OF PELVIC INFECTION. AS THE ANTIBIOTICS
Patient problems: Abdominal Pain; Anemia; Diarrhea; Fever; Purulent Discharge; Renal Failure; Tachycardia; Thrombosis; Thyroid Problems; Toxic Shock Syndrome; Unspecified Infection; Vomiting
MAUDE report 8731663 ↗
Other Cup, Menstrual devices
- Flex Reusable Menstrual Disc 10122The Flex Company · Cup, Menstrual26 reports
- Lena LENA-PUR-SLena Cup, LLC · Cup, Menstrual6 reports
- Flex Box of Flex 12 count (English only) VERTICALThe Flex Company · Cup, Menstrual6 reports
- Flex Cup and Flex Disc Flex Discovery Kit Slim FitThe Flex Company · Cup, Menstrual6 reports
- Cora 10MENSTRUALCUP-S1DTCCora · Cup, Menstrual5 reports
- Lena LENA-MIXII-2Lena Cup, LLC · Cup, Menstrual5 reports
- Lena LENA-RED-SLena Cup, LLC · Cup, Menstrual5 reports
- Lena LENA-GRN-SLena Cup, LLC · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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