Seventh Generation Regular, with plant-based plastic applicatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00732913451081), received between Jan 23, 2018 and Nov 10, 2023 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED THAT THE INDIVIDUAL WRAPPER OF ONE OF THE TAMPONS IN THE BOX WAS NOT FULLY SEALED ALTHOUGH THE BOX WAS IN PERFECT CONDITION. CONSUMER DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112017 ↗
• MalfunctionSep 22, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  CONSUMER REPORTED THAT 2 OUT OF THE FIRST 8 TAMPONS OUT OF A BOX OF 18 THE WITHDRAWAL STRING WAS MISSING AND TAMPON COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798227 ↗
• MalfunctionFeb 8, 2023Defective Component; No Apparent Adverse Event; Defective Component; No Apparent Adverse Event

  CONSUMER REPORTED THAT OPENING A NEW BOX OF TAMPONS, SO FAR 4 OF THE TAMPONS HAVE HAD A VERY SHORT STRING (1 INCH OR LESS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329145 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem

  CONSUMER HAS AN ALLERGIC REACTION TO OUR REGULAR COMFORT APPLICATOR TAMPON. ALLERGY WAS CONFIRMED BY ALLERGIST WITH 24 PATCH TEST.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11143862 ↗
• InjuryApr 16, 2020Use of Device Problem; Use of Device Problem

  CONSUMER USE SEVENTH GENERATION PLANT BASED PLASTIC APPLICATOR REGULAR TAMPON. DURING INSERTION CONSUMER HAD INSIDE PLUNGER PIECE PULL ALL THE WAY THROUGH OUTER TUBE AND REMAIN IN HER VAGINA. SHE WAS UNABLE TO RETRIEVE HERSELF, AND WENT TO THE EMERGENCY ROOM FOR ASSISTANCE AFTER HOURS. THEY WERE ABLE TO REMOVE THE OBJECT WITHOUT FURTHER INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9969030 ↗
• MalfunctionJun 28, 2019Difficult to Remove; Malposition of Device

  CUSTOMER INDICATED SHE HAD A DIFFICULT TIME REMOVING TAMPON BECAUSE TAMPON WAS INSERTED IN THE APPLICATOR UPSIDE DOWN LEADING TO UP SIDE DOWN INSERTION INTO HER BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8746232 ↗
• MalfunctionFeb 22, 2019Material Fragmentation

  CONSUMER INDICATED EXTRA PIECE OF PLASTIC FROM APPLICATOR LODGED IN COTTON WADING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362907 ↗
• InjuryNov 6, 2018Material Separation; Material Separation

  DURING INSERTION, PLASTIC APPLICATOR PLUNGER PUSHED ALL THE WAY THROUGH TAMPON HOUSING INTO CONSUMERS BODY. THIS HAPPENED ON BOTH ATTEMPTS.

  Patient problems: No Code Available

  MAUDE report 8044941 ↗
• InjuryJul 20, 2018Material Separation; Material Separation

  MY WIFE AND I HAVE BEEN LOYAL CUSTOMERS OF SEVENTH GENERATION BRAND FOR 10+ YEARS. RECENTLY ((B)(6) 2018) MY WIFE PURCHASED "SEVENTH GENERATION ORGANIC COTTON TAMPONS WITH COMFORT APPLICATOR" FROM (B)(6) AND TRIED TO USE IT DURING THE TRIP TO (B)(6). BUT WHEN SHE TRIED TO TAKE OUT THE APPLICATOR FROM HER BODY, THE APPLICATOR GOT SEPARATED FROM PLUNGER AND REMAINED INSIDE HER VAGINA. AFTER SEVERAL ATTEMPTS TO TAKE IT OUT OF HER BODY BY OURSELVES, WE NEEDED TO VISIT A LOCAL HOSPITAL AT NIGHT AND GOT HELPED FROM A GYNECOLOGIST TO TAKE THE PLASTIC PART OUT OF HER VAGINA. IT WAS COST/TIME-CONSUMING EXPERIENCE AWAY IN (B)(6) WHERE MY HEALTH INSURANCE IS NOT VALID AND THE SECURITY IS NOT SO GOOD AS IN THE U.S., AND EMOTIONALLY VERY DIFFICULT AS WELL. AFTER THE INCIDENT, WE COMPARED THE SG TAMPON WITH ONE OF THE OTHER BRANDS' TAMPON AND FOUND OUT THE OTHER BRAND'S APPLICATOR DOESN'T GET SEPARATED WHEN WE PULLED THE PLUNGER. THUS, I BELIEVE THAT THE MAIN REASON OF THE UNPLEASANT EXPERIENCE MY FAMILY HAD IS THE BAD DESIGN (EASILY SEPARATED) OF SEVENTH GENERATION TAMPON PRODUCT. I'D LIKE TO ASK SEVENTH GENERATION TO REIMBURSE THE COST WE NEEDED TO PAY AND COMPENSATE WHAT WE NEEDED TO EXPERIEN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7705814 ↗
• InjuryJan 23, 2018Detachment Of Device Component

  CONSUMER WAS USING THE PLASTIC APPLICATOR TAMPON WHEN THE SKINNY PORTION OF THE APPLICATOR CAME APART AND STAYED INSIDE HER VAGINA. THE CONSUMER WAS ABLE TO PULL THE PIECE OF APPLICATOR OUT BUT WAS CONCERNED IT HAPPENED SO EASILY. CONSUMER USED THE REMAINDER OF THE BOX OF TAMPONS AND HAD NO ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 7213857 ↗