OB 07012Recalls & reported problems
Edgewell Personal Care Brands, LLC · OB DIG HELIX ULTRA DK 40 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300070122), received between Aug 14, 2018 and Aug 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Patient Problem/Medical Problem1
- Toxic Shock Syndrome1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2018Patient-Device Incompatibility
CONSUMER IS A 28 YEAR OLD FEMALE WHO HAS BEEN USING OB TAMPONS SINCE HER MENSES STARTED AT THE AGE OF 12 YEARS. ON (B)(6) 2018 SHE SOUGHT MEDICAL ATTENTION AT AN URGENT CARE CENTER AND WAS DIAGNOSED WITH A VIRUS AND PRESCRIBED TYLENOL FOR FEVER AND BENADRYL FOR REDNESS. OVERNIGHT SHE REPORTED THAT THE FINGERS OF HER RIGHT HAND WENT NUMB, SHE CONTINUED TO HAVE A HIGH FEVER, HER HEART WAS RACING AND SHE WAS SWOLLEN AND RED ALL OVER. ON (B)(6) 2018 HER TEMPERATURE WAS 103 DEGREES. SHE SOUGHT MEDICAL ATTENTION WITH HER PRIMARY CARE PHYSICIAN (PCP) AND WAS TAKEN TO THE EMERGENCY ROOM (ER). ON (B)(6) 2018 SHE WAS SEEN BY THE INFECTIOUS DISEASE DOCTOR WHO WAS CERTAIN IT WAS TSS. SHE WAS TREATED FOR TOXIC SHOCK SYNDROME (TSS) WITH INTRAVENOUS THERAPY AND FIVE ANTIBIOTICS (NAMES UNKNOWN) AND THE FOLLOWING DAY WAS TRANSFERRED OUT OF THE CCU TO A REGULAR FLOOR. ON (B)(6) 2018 SHE WAS DISCHARGED FROM THE HOSPITAL. THE DIAGNOSIS OF TSS WAS CONFIRMED AT HER FOLLOW UP APPOINTMENT WITH THE INFECTIOUS DISEASE DOCTOR ON (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED ON 08/02/2018: CONSUMER IS A 28 YEAR OLD FEMALE WITH NO PRIOR MEDICAL OR SURGICAL HISTORY HAS BEEN USING OB TAMPONS SINCE HER MENSES STAR
Patient problems: Patient Problem/Medical Problem; Toxic Shock Syndrome
MAUDE report 7780849 ↗
Other TAMPON, MENSTRUAL, UNSCENTED devices
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- 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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