Devices › Tampon, menstrual, unscented
Device brand name · Tampon menstrual unscented
U By Kotex Sleek: medical device reports filed with FDA
1,288 reports name it, 2012–2019. Manufacturer given most often on reports: K-C Afc Manufacturing S De R L De C V. Product code HEB.
- 1,288
- device reports naming the brand
- 0% of all MAUDE reports · about 93 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.9%
- 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 1,288 reports that name the brand "U By Kotex Sleek" (tampon menstrual unscented), received between September 2012 and April 2019; the manufacturer given most often on reports is K-C Afc Manufacturing S De R L De C V. 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 (97.9%) and injury (2%); 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 (94.1%), difficult to remove (1.6%) and material fragmentation (0.8%). The patient problems coded most often are irritation, pain and device embedded in tissue or plaque. 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 Sleek 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
Who filed the report
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 | 1,212 | 94.1% | 46.3% |
| Difficult to removethe device was hard to remove | 21 | 1.6% | 5.3% |
| Material fragmentation | 10 | 0.8% | 2.3% |
| Material integrity problema problem with the device material | 10 | 0.8% | 0.7% |
| Breakthe device broke | 9 | 0.7% | 7.3% |
| Detachment of device component | 9 | 0.7% | 2.4% |
| Material disintegration | 7 | 0.5% | 0.5% |
| Unraveled material | 7 | 0.5% | 0.7% |
| Device contamination with chemical or other material | 6 | 0.5% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 0.4% | 0.4% |
| Component falling | 3 | 0.2% | 0.2% |
| Component missing | 2 | 0.2% | 3.3% |
| Contamination of device ingredient or reagent | 2 | 0.2% | 0.1% |
| Device contamination with body fluid | 2 | 0.2% | 0.1% |
| Device emits odor | 2 | 0.2% | 0.1% |
| Device packaging compromised | 2 | 0.2% | 0% |
| Crackthe device cracked | 1 | 0.1% | 0% |
| Device or device fragments location unknown | 1 | 0.1% | 0.1% |
| Insufficient device problem information | 1 | 0.1% | 16.7% |
| Looping | 1 | 0.1% | 0% |
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 |
|---|---|---|
| Irritationirritation | 388 | 30.1% |
| Painpain, site not specified | 76 | 5.9% |
| Device embedded in tissue or plaque | 64 | 5% |
| Abnormal vaginal discharge | 61 | 4.7% |
| Fungal infectiona fungal infection | 52 | 4% |
| Bacterial infectiona bacterial infection | 49 | 3.8% |
| Abdominal painstomach or belly pain | 45 | 3.5% |
| Urinary tract infectionbladder or urinary infection | 38 | 3% |
| Discomfortdiscomfort | 27 | 2.1% |
| Fever | 24 | 1.9% |
| Injurya physical injury | 21 | 1.6% |
| Nauseafeeling sick | 20 | 1.6% |
| Abdominal cramps | 19 | 1.5% |
| Intermenstrual bleeding | 15 | 1.2% |
| Headachehead pain | 14 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | U By Kotex Sleek | Product code HEB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,288 | 11,919 | 26,136,888 |
| Share of that pool | — | 10.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 2% | 9.4% | 36.2% |
| Classified as malfunction | 97.9% | 89.5% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 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% |
| U By Kotex Security | 266 | 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 Sleek reports
How many FDA reports name U By Kotex Sleek?
1,288 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 (97.9%) and injury (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (94.1%), difficult to remove (1.6%), material fragmentation (0.8%), material integrity problem (0.8%) and break (0.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). 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 Sleek 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.