Devices › System, thermal regulating
Device brand name · Bair hugger
Bair Hugger: medical device reports filed with FDA
408 reports name it, 1996–2025. Manufacturer given most often on reports: 3m. Product code DWJ.
- 408
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 1
- reports, 12 months to August 2026
- 2 in the 12 months before
- 6.4%
- classified as malfunction
- 90.9% across the product code
- 2.2%
- classified as death, as reported
- 9 reports · not verified by FDA
408 medical device reports received by FDA name the brand "Bair Hugger" (bair hugger); the manufacturer given most often on reports is 3m; received from September 1996 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 50% from 2 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 injury (85%), malfunction (6.4%) and other (4.7%); across all system, thermal regulating reports (product code DWJ) death is recorded in 0.2% and malfunction in 90.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are microbial contamination of device (39.7%), contamination (33.6%) and product quality problem (26%). The patient problems coded most often are post operative wound infection, injury 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
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 26,725 reports carrying product code DWJ. 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 |
|---|---|---|---|
| Microbial contamination of device | 162 | 39.7% | 1.2% |
| Contamination | 137 | 33.6% | 0.7% |
| Product quality problem | 106 | 26% | 0.9% |
| Nonstandard device | 31 | 7.6% | 2.3% |
| Contamination /decontamination problem | 25 | 6.1% | 0.2% |
| Device disinfection or sterilization issue | 13 | 3.2% | 0.1% |
| Contamination of device ingredient or reagent | 8 | 2% | 0% |
| Insufficient device problem information | 7 | 1.7% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.5% | 2.2% |
| Unexpected therapeutic results | 6 | 1.5% | 0.1% |
| Fail-safe design failure | 4 | 1% | 0% |
| Temperature problem | 4 | 1% | 6.9% |
| Inadequate filtration process | 2 | 0.5% | 0% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.5% | 1% |
| Manufacturing, packaging or shipping problem | 2 | 0.5% | 0% |
| Charred | 1 | 0.2% | 0% |
| Defective component | 1 | 0.2% | 13.1% |
| Device contamination with biological material | 1 | 0.2% | 0% |
| Device emits odor | 1 | 0.2% | 0.4% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.2% | 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 |
|---|---|---|
| Post operative wound infection | 97 | 23.8% |
| Injurya physical injury | 57 | 14% |
| Bacterial infectiona bacterial infection | 43 | 10.5% |
| Ambulation or postural difficulties | 34 | 8.3% |
| Painpain, site not specified | 23 | 5.6% |
| Staphylococcus aureus | 17 | 4.2% |
| Limited mobility of the implanted joint | 13 | 3.2% |
| Deaththe patient died; cause not stated by this term | 8 | 2% |
| Partial thickness (second degree) burn | 7 | 1.7% |
| Tissue damage | 5 | 1.2% |
| Disability | 4 | 1% |
| Sepsisa severe body-wide response to infection | 3 | 0.7% |
| Swellingswelling | 3 | 0.7% |
| Erosion | 2 | 0.5% |
| Erythemaskin redness | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bair Hugger | Product code DWJ | All MAUDE reports |
|---|---|---|---|
| Reports | 408 | 26,725 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 22 | 2 | 9 |
| Classified as injury | 85% | 8.2% | 36.2% |
| Classified as malfunction | 6.4% | 90.9% | 62.3% |
| Filed by the manufacturer | 2.9% | 95.8% | 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 DWJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Arctic Sun 5000 | 15,438 | 1,032 | 0% |
| Arctic Sun Stat | 1,537 | 336 | 0.1% |
| Arctic Sun Temperature Management System, ArcticGel Pads | 1,137 | 186 | 0% |
| Arcticsun 5000 | 908 | 0 | 0.3% |
| Arctic Sun Temperature Management System Temperature Cable | 601 | 0 | 0% |
| Arctic Sun Model 5000 Temperature Management System | 565 | 0 | 0.2% |
| Unknown ArcticGel Pads | 517 | 20 | 0% |
| Arcticgel Pads | 322 | 0 | 0.3% |
| Arctic Sun Temperature Management System | 313 | 0 | 0% |
| Arctic Gel Pads | 239 | 0 | 0.4% |
| Artic Sun 5000 115v Na | 240 | 0 | 0% |
| Altrix Domestic | 217 | 0 | 0% |
| Unknown Arctic Sun Temperature Cable | 184 | 83 | 0% |
| Arcticsun Gel Pads | 155 | 0 | 0% |
| Unknown_Medical_Product | 672 | 34 | 2.2% |
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 Bair Hugger reports
How many FDA reports name Bair Hugger?
408 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (85%), malfunction (6.4%) and other (4.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
microbial contamination of device (39.7%), contamination (33.6%), product quality problem (26%), nonstandard device (7.6%) and contamination /decontamination problem (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (87.3%) and manufacturer reports (2.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bair Hugger 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.