Cora 02Tampons-315Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850003218328), received between May 21, 2021 and May 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A USER CONTACTED SUPPORT INDICATING THAT SHORTLY AFTER INSERTING A LIGHT ABSORBENCY TAMPON AT THE END OF THEIR PERIOD THEY STARTED HAVING DIZZINESS, ANXIETY, AND FEELING LIKE THEY WERE GOING TO PASS OUT. LATER THEY HAD CHILLS THROUGHOUT THEIR ENTIRE BODY WHICH CAUSED THEM TO SHAKE AGGRESSIVELY. THEY THEN STARTED GETTING A FEVER AND HAD SYMPTOMS OF HYPOTENSION. THEY REALIZED THEY STARTED FEELING TERRIBLE AFTER PUTTING A TAMPON IN SO THEY IMMEDIATELY TOOK IT OUT AND WITHIN 20 MINUTES ALL SYMPTOMS WERE GONE. THE TAMPON WAS IN FOR LESS THAN 2 HOURS TOTAL. THE USER STATED THAT THEY HAD NEVER EXPERIENCED THIS SET OF SYMPTOMS BEFORE WITH A PERIOD PRODUCT, IT WAS NOT THEIR FIRST TIME USING A TAMPON, THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS/ALLERGIES/DRUGS THAT MIGHT HAVE CAUSED THIS TO OCCUR. THE USER DID NOT SEEK MEDICAL ATTENTION BECAUSE THE SYMPTOMS WENT AWAY. ALTHOUGH UNCONFIRMED, THESE SYMPTOMS ARE CONSISTENT WITH THE ONSET OF TSS AND THEREFORE ARE BEING REPORTED AS AN ADVERSE EVENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 19328641 ↗
• InjuryMay 21, 2021Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  A MOTHER CONTACTED SUPPORT INDICATING THAT HER MINOR DAUGHTER EXPERIENCED A TAMPON UNRAVELING DURING REMOVAL. THE TAMPON WAS IN PLACE FOR LESS THAN 4 HRS AND WAS DRY UPON REMOVAL DUE TO LIGHT FLOW. THE ABSORBENCY USED DURING THE EVENT WAS UNKNOWN, AND THE DRAWER FROM WHICH THE TAMPON WAS DRAWN BY THE USER HAD A MIX OF MULTIPLE BRANDS IN IT. THE USER WAS TAKEN TO A GYNECOLOGIST WHERE THE REMAINING FIBERS WERE REMOVED FROM HER VAGINA. AFTER A FOLLOW-UP APPOINTMENT WITH THE GYNECOLOGIST THE USER WAS PRESCRIBED TWO COURSES OF TWO DIFFERENT ANTIBIOTICS, TYPE AND ROUTE OF ADMINISTRATION WERE NOT SPECIFIED.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection

  MAUDE report 11866370 ↗