OB 07008Recalls & reported problems
Edgewell Personal Care Brands, LLC · OB DIG HELIX REG AL 40 · 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 00078300070085), received between Dec 1, 2020 and Dec 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2020Detachment of Device or Device Component
A FEMALE CONSUMER, OVER THE AGE OF 18, REPORTED THAT SHE USED A TAMPON AND WHEN SHE TRIED TO REMOVE THE PLUG, THE STRING CAME OUT COMPLETELY. CONSUMER STATED THAT ON THE SAME DAY SHE HAD TO GO TO THE DOCTOR'S OFFICE TO HAVE THE TAMPON REMOVED. A CULTURE WAS PERFORMED AND THE DOCTOR RECOMMENDED THAT SHE NOT USE TAMPONS FOR AWHILE TO ALLOW HER BODY TO CYCLE AND HEAL. NO MEDICATION OR TREATMENT WAS PRESCRIBED AND NO FOLLOW UP APPOINTMENT WAS NEEDED. THE CONSUMER REPORTED THAT SHE WAS HEALING. ADDITIONAL INFORMATION 12/09/2020: INVESTIGATION RESULTS ADDED IN ADDITIONAL MANUFACTURER NARRATIVE SECTION.
Patient problems: Insufficient Information
MAUDE report 10928599 ↗
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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