Cora 02Tampons-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850373007379), received between Aug 6, 2020 and Feb 5, 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.

• InjuryFeb 5, 2024Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  MID-CYCLE, USER INSERTED A NEW TAMPON. WITHIN AN HOUR AFTER INSERTION THE USER BEGAN TO FEEL EXTREMELY SICK. SYMPTOMS: EXTREME HEADACHE, DIZZINESS, SHARP ABDOMINAL PAIN, AND BODY ACHES. USER LEFT WORK AND REMOVED TAMPON. UPON REMOVAL THE TAMPON WAS UNRAVELING AND HAD A "HARD DARK PLASTIC THING INSIDE THE COTTON" WHICH WAS DISCOVERED AFTER PICKING THE TAMPON APART. WITHIN 10 MINUTES OF REMOVING TAMPON THE USER'S ABDOMINAL PAIN SUBSIDED AND BY THE END OF THE DAY ALL SYMPTOMS WERE GONE. BECAUSE OF COVID, USER CONSULTED A HEALTHCARE PROVIDER VIA TELEMEDICINE AND FROM THE SYMPTOMS THE HEALTHCARE PROVIDER DETERMINED THAT THE USER MORE THAN LIKELY EXPERIENCED TSS.

  Patient problems: Toxic Shock Syndrome

  MAUDE report 18640368 ↗
• InjuryAug 6, 2020Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  MID-CYCLE, USER INSERTED A NEW TAMPON. WITHIN AN HOUR AFTER INSERTION THE USER BEGAN TO FEEL EXTREMELY SICK. SYMPTOMS: EXTREME HEADACHE, DIZZINESS, SHARP ABDOMINAL PAIN, AND BODY ACHES. USER LEFT WORK AND REMOVED TAMPON. UPON REMOVAL THE TAMPON WAS UNRAVELING AND HAD A "HARD DARK PLASTIC THING INSIDE THE COTTON" WHICH WAS DISCOVERED AFTER PICKING THE TAMPON APART. WITHIN 10 MINUTES OF REMOVING TAMPON THE USER'S ABDOMINAL PAIN SUBSIDED AND BY THE END OF THE DAY ALL SYMPTOMS WERE GONE. BECAUSE OF COVID, USER CONSULTED A HEALTHCARE PROVIDER VIA TELEMEDICINE AND FROM THE SYMPTOMS THE HEALTHCARE PROVIDER DETERMINED THAT THE USER MORE THAN LIKELY EXPERIENCED TSS. NO INJURY OR MEDICAL INTERVENTION NEEDED WAS REPORTED.

  Patient problems: Toxic Shock Syndrome

  MAUDE report 10371813 ↗