Reported Reactions

Devices › Tampon, menstrual, unscented

Device brand name · Tampon menstrual unscented - heb

Tampax Tampon, Version/Absorbency/Scent Unknown: medical device reports filed with FDA

610 reports name it, 2016–2026. Manufacturer given most often on reports: Tambrands Manufacturing. Product code HEB.

610
device reports naming the brand
0% of all MAUDE reports · about 60 a year
83
reports, 12 months to August 2026
77 in the 12 months before
97%
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 610 reports that name the brand "Tampax Tampon, Version/Absorbency/Scent Unknown" (tampon menstrual unscented - heb), received between May 2016 and August 2026; the manufacturer given most often on reports is Tambrands Manufacturing. Spellings of one product vary from report to report.

83 reports arrived in the 12 months to August 2026, close to the 77 of 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%) and injury (3%); 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.

Reports by month, five years

0918Sep 2021: 7Oct 2021: 2Nov 2021: 5Dec 2021: 72022Jan 2022: 9Feb 2022: 15Mar 2022: 9Apr 2022: 8May 2022: 3Jun 2022: 12Jul 2022: 11Aug 2022: 6Sep 2022: 9Oct 2022: 5Nov 2022: 6Dec 2022: 72023Jan 2023: 4Feb 2023: 4Mar 2023: 8Apr 2023: 4May 2023: 6Jun 2023: 11Jul 2023: 17Aug 2023: 8Sep 2023: 18Oct 2023: 7Nov 2023: 13Dec 2023: 82024Jan 2024: 3Feb 2024: 15Mar 2024: 7Apr 2024: 8May 2024: 7Jun 2024: 9Jul 2024: 4Aug 2024: 7Sep 2024: 3Oct 2024: 8Nov 2024: 5Dec 2024: 52025Jan 2025: 8Feb 2025: 5Mar 2025: 8Apr 2025: 9May 2025: 7Jun 2025: 5Jul 2025: 6Aug 2025: 8Sep 2025: 11Oct 2025: 5Nov 2025: 6Dec 2025: 52026Jan 2026: 7Feb 2026: 6Mar 2026: 8Apr 2026: 8May 2026: 6Jun 2026: 8Jul 2026: 2Aug 2026: 11

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

0541082016: 320162019: 320192020: 9220202021: 8420212022: 10020222023: 10820232024: 8120242025: 8320252026: 562026

Event type and report source

Event type, as classified on the report

Death0%0
Injury3%18
Malfunction97%592
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%610
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)ReportsShareShare across product code
Insufficient device problem information43070.5%16.7%

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)ReportsShare
Foreign body in patientpart of a device left in the patient38262.6%
Painpain, site not specified6310.3%
Discomfortdiscomfort294.8%
Appropriate clinical signs, symptoms and conditions term/code not available172.8%
Abnormal vaginal discharge122%
Device embedded in tissue or plaque101.6%
Abdominal painstomach or belly pain81.3%
Vaginal mucosa damage81.3%
Itching sensation61%
Abdominal cramps50.8%
Burning sensationa burning feeling40.7%
Fever40.7%
Malaisegeneral feeling of being unwell40.7%
Nauseafeeling sick40.7%
Anxietyanxiety30.5%

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

In context

MeasureTampax Tampon, Version/Absorbency/Scent UnknownProduct code HEBAll MAUDE reports
Reports61011,91926,136,888
Share of that pool—5.1%0%
Classified as death, per 1,000 reports019
Classified as injury3%9.4%36.2%
Classified as malfunction97%89.5%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
U by Kotex Click : Tampon, Menstrual, Unscented : HEB2,373570%
U By Kotex Sleek1,28800%
U By Kotex Security Tampon Menstrual Unscented Heb91200%
U By Kotex Unknown Tampon Menstrual Unscented Heb72900%
U By Kotex Click60000%
U By Kotex Sleek Tampon Menstrual Unscented Heb50400%
U By Kotex Click Tampons37300%
U By Kotex Security26600%

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 Tampax Tampon, Version/Absorbency/Scent Unknown reports

How many FDA reports name Tampax Tampon, Version/Absorbency/Scent Unknown?

610 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 83 in the latest 12 months.

What kinds of events are reported?

malfunction (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (70.5%). 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 Tampax Tampon, Version/Absorbency/Scent Unknown 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.