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Seventh Generation Regular, with applicatorRecalls & reported problems

Seventh Generation, Inc. · Organic Cotton Applicator Tampons, Regular · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732913451036), received between Aug 6, 2019 and Aug 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Misassembled” (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

Device problems

  • Misassembled2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionAug 6, 2019Misassembled; Misassembled

    CUSTOMER RECEIVED A CARDBOARD TAMPON THAT HAD A BROKEN PETAL ON THE TOP OF THE APPLICATOR.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8867823 ↗
  • MalfunctionAug 6, 2019Misassembled; Misassembled

    CUSTOMER INSERTED TAMPON AND NOTICED A SECOND PARTIAL TAMPON IN THE SAME APPLICATOR. CUSTOMER REMOVED TAMPONS AND WENT TO URGENT CARE TP ENSURE NO RESIDUAL COMPONENTS WERE IN HER BODY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8867794 ↗

Other Tampon, Menstrual, Unscented devices

All Tampon, Menstrual, Unscented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.