Seventh Generation Super, with plant-based plastic applicatorRecalls & reported problems
Seventh Generation, Inc. · Organic Cotton Comfort Applicator Tampons, Super (plant-based plastic applicator) · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00732913451098), received between May 1, 2019 and Mar 25, 2021 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Misassembled” (5 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Misassembled5
- Contamination /Decontamination Problem1
- Product Quality Problem1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Discomfort1
- Irritation1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2021Contamination /Decontamination Problem
FORIEGN METAL OBJECT FOUND IN TAMPON WHEN CUSTOMER REMOVED AFTER USE. NO INJURY SUSTAINED.
Patient problems: Foreign Body In Patient
MAUDE report 11573055 ↗MalfunctionJun 30, 2020Misassembled; Misassembled
CONSUMER WAS UNABLE TO FIND STRING WHEN REMOVING TAMPON. WHEN SHE WAS ABLE TO REMOVE IT SHE NOTICED THAT TAMPON WAS INSERTED INTO THE APPLICATOR UPSIDE DOWN.
Patient problems: No Code Available
MAUDE report 10214770 ↗MalfunctionAug 30, 2019Misassembled; Misassembled
PLUNGER FROM APPLICATOR REMAINED IN BODY AFTER INSERTION. SUPER AND REGULAR TYPES. SUPER: (B)(4). REGULAR: (B)(4).
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8949855 ↗InjuryAug 30, 2019Misassembled; Misassembled
CUSTOMER USED TAMPON AND REMOVED BEFORE BED. WHEN CUSTOMER WOKE UP IN THE MORNING TO USE THE BATHROOM SOME KIND OF MATERIAL FELL OUT OF VAGINA INTO TOILET. CUSTOMER THINKS IT MAY BE PART OF TAMPON, BUT NOTICED NOT IRREGULARITIES IN THE TAMPON PRIOR TO USE.
Patient problems: Foreign Body In Patient
MAUDE report 8949807 ↗MalfunctionJun 28, 2019Misassembled; Misassembled
CUSTOMER INDICATED INSERTED A TAMPON THAT WAS INVERTED INSIDE OF THE APPLICATOR. THIS MADE REMOVAL DIFFICULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8746169 ↗InjuryJun 26, 2019Product Quality Problem
CUSTOMER TRIED OUR TAMPON AND INDICATED THEY WERE DRY AND UNCOMFORTABLE. SHE INDICATED THEY CAUSED IRRITATION WHERE SHE REACHED OUT TO HER OBGYN WHO RECOMMENDED DISCONTINUING USE.
Patient problems: Discomfort; Irritation
MAUDE report 8736900 ↗MalfunctionMay 1, 2019Misassembled; Misassembled
A LONG TIME USER OF SEVENTH GENERATION TAMPONS INSERTED A SUPER COMFORT APPLICATOR TAMPON . AFTER INSERTION SHE NOTICED THERE WAS NO STRING. SHE STRUGGLED TO GET IT OUT UNTIL HER HUSBAND WAS EVENTUALLY ABLE TO RETRIEVE IT. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8569734 ↗
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
- Daye FG-TMP-MM-IB18180000Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-RET09000900Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-MM-REF18180000Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.