Cora 02Tampons-317-ORecalls & reported problems
Cora · 100% Organic Cotton Bio PE Applicator Tampons, Retail, Super/Super+ 32 · Class 2
Data updated Oct 18, 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 00810042480520), received between Sep 26, 2024 and Sep 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ON THE FIRST DAY OF HEAVY BLEEDING, SHE USED A SUPER PLUS TAMPON. AFTER REMOVING IT, SHE NOTICED THAT ONLY THE BARREL REMAINED AND FELT SMALLER THAN EXPECTED. SHE CHECKED INSIDE BUT COULDN'T FEEL ANYTHING, SO SHE INSERTED ANOTHER TAMPON. EACH TIME SHE REMOVED A TAMPON, SHE CHECKED WITH HER FINGERS, BUT FELT NOTHING UNUSUAL INTERNALLY. OVER THE NEXT FEW DAYS, SHE EXPERIENCED INCREASING NAUSEA AND UTERINE PAIN, WITH HER CRAMPS GETTING WORSE. EVENTUALLY, SHE HAD DIFFICULTY BENDING AND WALKING. WHILE URINATING, SHE COUGHED AND FELT SOMETHING FOREIGN INSIDE. UPON REACHING IN, SHE DETECTED A PLASTIC-LIKE OBJECT. AT THE ER, THE DOCTOR PERFORMED A PAP SMEAR AND USED A SPECULUM, DISCOVERING A TAMPON APPLICATOR STUCK SIDEWAYS. THE DOCTOR NOTED SWELLING AND SCRATCHES, AND SAID IT WOULD HAVE BEEN IMPOSSIBLE FOR HER TO REMOVE IT ON HER OWN. THE APPLICATOR WAS LODGED INSIDE HER FOR 6 DAYS. NO MEDICATION WAS PRESCRIBED.
Patient problems: Foreign Body Reaction
MAUDE report 20311877 ↗
Other Tampon, Menstrual, Unscented devices
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented178 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall2 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall1 report
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- Daye FG-TMP-REF00090009Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-RET00090009Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 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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