OB 07015Recalls & reported problems
Edgewell Personal Care Brands, LLC · OB DIG PROC MP 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 00078300070153), received between Jun 20, 2019 and Jun 20, 2019 — 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
- Abdominal Cramps1
- Abdominal Pain1
- Headache1
- Nausea1
- Vaginal Mucosa Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2019Patient-Device Incompatibility
ON (B)(6) 2019 A FEMALE CONSUMER REPORTED THAT SHE HAD BEEN USING OB TAMPONS FOR YEARS AND YEARS AND IN (B)(6) 2018 SHE STARTED HAVING PAIN AND DISCOMFORT. SHE STATED THAT SHE WENT TO THE EMERGENCY ROOM WHERE THEY TESTED HER FOR DRUGS, CHECKED HER T-CELL COUNT AND DID A PREGNANCY TEST. SHE STATED THAT THEY DID NOT BELIEVE HER AND THOUGHT SHE WAS TRYING TO GET DRUGS SO REFERRED HER TO A PSYCHIATRIST. SHE STATED THAT SHE STOPPED USING TAMPONS UNTIL (B)(6) 2019 AND AFTER A FEW DAYS THE TAMPONS GAVE HER THE SAME SYMPTOMS AS IN (B)(6) 2018, NAUSEA, HEADACHE AND CRAMPS AND SHE WAS IN A LOT OF PAIN. CONSUMER STATED THAT SHE WAS TAKING NAPROXEN FOR CRAMPS. CONSUMER STATED THAT PRIOR TO THE EMERGENCY ROOM VISIT IN (B)(6) 2018, SHE SAW HER PRIMARY CARE PHYSICIAN (PCP) FOR PELVIC DISCOMFORT AND APPENDICITIS WAS RULED OUT, PELVIC AND VAGINAL ULTRASOUNDS WERE NEGATIVE AND NOTHING WAS FOUND. SHE STATED THAT WHEN SHE DISCONTINUED USING THE PRODUCT HER SYMPTOMS IMPROVED. CONSUMER REPORTED THAT HER PCP EXAMINED HER ON (B)(6) 2019 AND STATED THAT SHE "APPEARED TO HAVE IRRITATED WHITE CELLS". SHE STATED THAT SHE HAS NOT SEEN HER OB-GYN DOCTOR SINCE (B)(6) 2018 WHEN A PAP TEST WAS DONE. SHE STATED THA
Patient problems: Abdominal Cramps; Abdominal Pain; Headache; Nausea; Vaginal Mucosa Damage
MAUDE report 8718378 ↗
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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