Devices › Tampon, menstrual, unscented
Device brand name · Tampon menstrual unscented
U by Kotex Click : Tampon, Menstrual, Unscented : HEB: medical device reports filed with FDA
2,373 reports name it, 2014–2026. Manufacturer given most often on reports: K-C Afc Manufacturing S De R L De C V. Product code HEB.
- 2,373
- device reports naming the brand
- 0% of all MAUDE reports · about 201 a year
- 57
- reports, 12 months to August 2026
- 52 in the 12 months before
- 99.4%
- 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 2,373 reports that name the brand "U by Kotex Click : Tampon, Menstrual, Unscented : HEB" (tampon menstrual unscented), received between September 2014 and August 2026; 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.
57 reports arrived in the 12 months to August 2026, up 10% from 52 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 (99.4%) and injury (0.6%); 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 (70.1%), break (11.2%) and difficult to remove (7.1%). The patient problems coded most often are pain, discomfort and foreign body in patient. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 | 1,663 | 70.1% | 46.3% |
| Breakthe device broke | 265 | 11.2% | 7.3% |
| Difficult to removethe device was hard to remove | 168 | 7.1% | 5.3% |
| Component missing | 147 | 6.2% | 3.3% |
| Product quality problem | 119 | 5% | 2.7% |
| Sharp edges | 21 | 0.9% | 0.4% |
| Defective component | 18 | 0.8% | 0.2% |
| Material fragmentation | 17 | 0.7% | 2.3% |
| Detachment of device component | 12 | 0.5% | 2.4% |
| Difficult to insertthe device was hard to insert | 11 | 0.5% | 0.2% |
| Component falling | 8 | 0.3% | 0.2% |
| Unraveled material | 6 | 0.3% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 0.2% | 0.4% |
| Device contamination with body fluid | 4 | 0.2% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 4 | 0.2% | 0.1% |
| Insufficient device problem information | 3 | 0.1% | 16.7% |
| Manufacturing, packaging or shipping problem | 3 | 0.1% | 0.1% |
| Material integrity problema problem with the device material | 2 | 0.1% | 0.7% |
| Material twisted/bent | 2 | 0.1% | 0% |
| Split | 2 | 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 |
|---|---|---|
| Painpain, site not specified | 139 | 5.9% |
| Discomfortdiscomfort | 76 | 3.2% |
| Foreign body in patientpart of a device left in the patient | 51 | 2.1% |
| Abdominal cramps | 25 | 1.1% |
| Bacterial infectiona bacterial infection | 25 | 1.1% |
| Fever | 23 | 1% |
| Abnormal vaginal discharge | 22 | 0.9% |
| Irritationirritation | 19 | 0.8% |
| Abdominal painstomach or belly pain | 18 | 0.8% |
| Cramp(s) /muscle spasm(s) | 18 | 0.8% |
| Headachehead pain | 18 | 0.8% |
| Nauseafeeling sick | 18 | 0.8% |
| Skin inflammation/ irritation | 17 | 0.7% |
| Burning sensationa burning feeling | 14 | 0.6% |
| Device embedded in tissue or plaque | 14 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | U by Kotex Click : Tampon, Menstrual, Unscented : HEB | Product code HEB | All MAUDE reports |
|---|---|---|---|
| Reports | 2,373 | 11,919 | 26,136,888 |
| Share of that pool | — | 19.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.6% | 9.4% | 36.2% |
| Classified as malfunction | 99.4% | 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 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% |
| 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 Click : Tampon, Menstrual, Unscented : HEB reports
How many FDA reports name U by Kotex Click : Tampon, Menstrual, Unscented : HEB?
2,373 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.
What kinds of events are reported?
malfunction (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (70.1%), break (11.2%), difficult to remove (7.1%), component missing (6.2%) and product quality problem (5%). 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 Click : Tampon, Menstrual, Unscented : HEB 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.