Device brand name · Tampon menstrual unscented

U By Kotex Security: medical device reports filed with FDA

266 reports name it, 2016–2019. Manufacturer given most often on reports: Kimberly-Clark Conway Mill. Product code HEB.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

266
device reports naming the brand: 0% of all MAUDE reports · about 27 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 96.2%
classified as malfunction: 89.5% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 266 reports that name the brand "U By Kotex Security" (tampon menstrual unscented), received between August 2016 and April 2019; the manufacturer given most often on reports is Kimberly-Clark Conway Mill. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.2%) and injury (3.8%); across all tampon, menstrual, unscented reports (product code HEB) death is recorded in 0.1% and malfunction in 89.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material separation (95.9%), material integrity problem (1.5%) and difficult to remove (0.8%). The patient problems coded most often are abnormal vaginal discharge, pain and bacterial infection. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming U By Kotex Security was received in the five years to August 2026; the latest was received in April 2019.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury3.8%10

Malfunction96.2%256

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%266

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 11,919 reports carrying product code HEB. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Material separation	255	95.9%	46.3%
Material integrity problema problem with the device material	4	1.5%	0.7%
Difficult to removethe device was hard to remove	2	0.8%	5.3%
Breakthe device broke	1	0.4%	7.3%
Component missing	1	0.4%	3.3%
Defective component	1	0.4%	0.2%
Device damaged prior to usethe device was damaged before use	1	0.4%	0.1%
Product quality problem	1	0.4%	2.7%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Abnormal vaginal discharge	29	10.9%
Painpain, site not specified	23	8.6%
Bacterial infectiona bacterial infection	21	7.9%
Fever	14	5.3%
Abdominal painstomach or belly pain	11	4.1%
Discomfortdiscomfort	11	4.1%
Fungal infectiona fungal infection	11	4.1%
Abdominal cramps	9	3.4%
Irritationirritation	7	2.6%
Chillschills or shivering	6	2.3%
Itching sensation	6	2.3%
Nauseafeeling sick	6	2.3%
Headachehead pain	5	1.9%
Dizzinesslight-headedness or unsteadiness	3	1.1%
Intermenstrual bleeding	3	1.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	U By Kotex Security	Product code HEB	All MAUDE reports
Reports	266	11,919	26,136,888
Share of that pool	—	2.2%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	3.8%	9.4%	36.2%
Classified as malfunction	96.2%	89.5%	62.3%
Filed by the manufacturer	100%	95.5%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code HEB

Brand	Reports	Latest 12 months	Classified as death
U by Kotex Click : Tampon, Menstrual, Unscented : HEB	2,373	57	0%
U By Kotex Sleek	1,288	0	0%
U By Kotex Security Tampon Menstrual Unscented Heb	912	0	0%
U By Kotex Unknown Tampon Menstrual Unscented Heb	729	0	0%
Tampax Tampon, Version/Absorbency/Scent Unknown	610	83	0%
U By Kotex Click	600	0	0%
U By Kotex Sleek Tampon Menstrual Unscented Heb	504	0	0%
U By Kotex Click Tampons	373	0	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about U By Kotex Security reports

How many FDA reports name U By Kotex Security?

266 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (96.2%) and injury (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material separation (95.9%), material integrity problem (1.5%), difficult to remove (0.8%), break (0.4%) and component missing (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that U By Kotex Security was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.