Devices › Continuous measurement thermometer
Device brand name · Thermometer
Braun: medical device reports filed with FDA
365 reports name it, 1997–2026. Manufacturer given most often on reports: Kaz USA A Helen Of Troy. Product code FLL.
- 365
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 24
- reports, 12 months to August 2026
- 26 in the 12 months before
- 71.8%
- classified as malfunction
- 74.4% across the product code
- 0.5%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 365 reports that name the brand "Braun" (thermometer), received between January 1997 and August 2026; the manufacturer given most often on reports is Kaz USA A Helen Of Troy. Spellings of one product vary from report to report.
24 reports arrived in the 12 months to August 2026, close to the 26 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 (71.8%), other (14%) and injury (13.4%); across all continuous measurement thermometer reports (product code FLL) death is recorded in 1% and malfunction in 74.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are false negative result (47.7%), insufficient device problem information (15.9%) and low readings (4.7%). The patient problems coded most often are fever, seizures and convulsion/seizure. 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 1,321 reports carrying product code FLL. 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 |
|---|---|---|---|
| False negative result | 174 | 47.7% | 15.5% |
| Insufficient device problem information | 58 | 15.9% | 6.2% |
| Low readingsreadings were too low | 17 | 4.7% | 7.4% |
| Low test results | 17 | 4.7% | 2.3% |
| Defective devicethe device was defective | 8 | 2.2% | 0.5% |
| Patient device interaction problem | 8 | 2.2% | 0.6% |
| High readingsreadings were too high | 7 | 1.9% | 2.8% |
| Device reprocessing problem | 5 | 1.4% | 0.7% |
| Fluid/blood leak | 5 | 1.4% | 0.1% |
| Improper or incorrect procedure or method | 5 | 1.4% | 1.4% |
| Breakthe device broke | 4 | 1.1% | 1.8% |
| Leak/splashthe device leaked | 4 | 1.1% | 0.2% |
| Incorrect, inadequate or imprecise result or readings | 3 | 0.8% | 5.7% |
| Device handling problem | 2 | 0.5% | 0.1% |
| Failure to disconnect | 2 | 0.5% | 0% |
| Calibration error | 1 | 0.3% | 0.3% |
| Circuit failure | 1 | 0.3% | 0% |
| Component missing | 1 | 0.3% | 0.2% |
| Component(s), broken | 1 | 0.3% | 0.2% |
| Contamination /decontamination problem | 1 | 0.3% | 0.1% |
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 |
|---|---|---|
| Fever | 230 | 63% |
| Seizures | 21 | 5.8% |
| Convulsion/seizure | 11 | 3% |
| Viral infectiona viral infection | 10 | 2.7% |
| Misdiagnosis | 3 | 0.8% |
| Missed dose | 3 | 0.8% |
| Bacterial infectiona bacterial infection | 2 | 0.5% |
| Bronchitischest infection | 2 | 0.5% |
| Pneumonialung infection | 2 | 0.5% |
| Sepsisa severe body-wide response to infection | 2 | 0.5% |
| Asthmaasthma | 1 | 0.3% |
| Autoimmune disorder | 1 | 0.3% |
| Deaththe patient died; cause not stated by this term | 1 | 0.3% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.3% |
| Ear infectionan ear infection | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Braun | Product code FLL | All MAUDE reports |
|---|---|---|---|
| Reports | 365 | 1,321 | 26,136,888 |
| Share of that pool | — | 27.6% | 0% |
| Classified as death, per 1,000 reports | 5 | 10 | 9 |
| Classified as injury | 13.4% | 13.1% | 36.2% |
| Classified as malfunction | 71.8% | 74.4% | 62.3% |
| Filed by the manufacturer | 81.1% | 77.2% | 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 FLL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pro 6000 W/Small Cradle | 235 | 0 | 0% |
| Vicks | 212 | 5 | 0.5% |
| Bair Hugger | 408 | 1 | 2.2% |
| Deroyal | 587 | 14 | 0.7% |
| Level 1 | 628 | 0 | 0.5% |
| Nellcor | 1,814 | 215 | 3.9% |
| Philips | 190 | 0 | 6.3% |
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 Braun reports
How many FDA reports name Braun?
365 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
malfunction (71.8%), other (14%) and injury (13.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false negative result (47.7%), insufficient device problem information (15.9%), low readings (4.7%), low test results (4.7%) and defective device (2.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (81.1%) and voluntary reports (15.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Braun 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.