OB 02993Recalls & reported problems
Edgewell Personal Care Brands, LLC · OB ORGANIC SUP APLC 18ct 4/3 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300029939), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Expulsion” (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 16, 2026.
Most reported problems
Device problems
- Expulsion1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2019Expulsion; Expulsion
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT SHE HAD BEEN USING OB PRODUCTS SINCE THE MID 1990'S AND USUALLY USED THE OB TAMPONS WITHOUT THE APPLICATORS BUT DECIDED SINCE OB PUT OUT A NEW PLANT-BASED APPLICATOR, SHE WOULD GIVE THE PRODUCT A TRY. SHE STATED THAT SINCE SHE USED THE APPLICATOR VERSION OF THE PRODUCT, SHE NOTICED SHE WAS HAVING SYMPTOMS OF FEVER, PAIN, FOUL ODOROUS DISCHARGE AND PAIN UPON URINATION. SHE STATED THAT SHE DID NOT USE ANY OVER THE COUNTER PRODUCTS BECAUSE SHE HAS MULTIPLE HEALTH ISSUES AND WAS GOING FOR FERTILITY ASSISTANCE AND DID NOT WANT TO AFFECT THAT PROCESS. SHE STATED THAT SHE WENT TO THE GYNECOLOGIST ON (B)(6) 2019, THE DOCTOR DID A VAGINAL EXAM AND FOUND A TRIANGULAR SHAPED, ONE INCH PIECE OF THE APPLICATOR INSIDE OF HER WHICH WAS REMOVED. SHE DID NOT KNOW IF THE PIECE OF APPLICATOR WAS DISCARDED. SHE REPORTED THAT SHE WAS DIAGNOSED WITH A BACTERIAL VAGINAL INFECTION AND PRESCRIBED FLAGYL. SHE STATED THAT THE DOCTOR SAID THAT HE BELIEVED THAT THE INFECTION WILL CLEAR UP SINCE THE PIECE OF PLASTIC WAS REMOVED. NO FOLLOW-UP WITH THE GYNECOLOGIST WAS NEEDED. SHE STATED THAT SHE HAD A FERTILITY TREATMENT AFTER USING THE TAMPONS SO COULD
Patient problems: Bacterial Infection
MAUDE report 9147669 ↗
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
- TampaxProcter & Gamble Manufacturing Company, The · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- TampaxProcter & Gamble Manufacturing Company, The · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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