Devices › Pad, heating, powered
Device brand name · Heating pad
Softheat: medical device reports filed with FDA
251 reports name it, 2010–2021. Manufacturer given most often on reports: Kaz. Product code IRT.
- 251
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.6%
- classified as malfunction
- 70.1% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 251 reports that name the brand "Softheat" (heating pad), received between February 2010 and June 2021; the manufacturer given most often on reports is Kaz. 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 other (64.1%), injury (33.9%) and malfunction (1.6%); across all pad, heating, powered reports (product code IRT) death is recorded in 0.2% and malfunction in 70.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are improper or incorrect procedure or method (57.8%), insufficient device problem information (10.8%) and overheating of device (5.2%). The patient problems coded most often are partial thickness (second degree) burn, burn, thermal and full thickness (third degree) burn. 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 Softheat was received in the five years to August 2026; the latest was received in June 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,882 reports carrying product code IRT. 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 |
|---|---|---|---|
| Improper or incorrect procedure or method | 145 | 57.8% | 7.9% |
| Insufficient device problem information | 27 | 10.8% | 4.4% |
| Overheating of device | 13 | 5.2% | 4.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 4.4% | 1.5% |
| Fire | 10 | 4% | 8% |
| Temperature problem | 9 | 3.6% | 1.2% |
| Human-device interface problem | 4 | 1.6% | 0% |
| Melted | 4 | 1.6% | 2.2% |
| Thermal decomposition of device | 4 | 1.6% | 15.6% |
| Entrapment of device | 3 | 1.2% | 0% |
| Smoking | 3 | 1.2% | 5.1% |
| Breakthe device broke | 2 | 0.8% | 2.9% |
| Device inoperablethe device could not be used | 2 | 0.8% | 1.6% |
| Device slipped | 2 | 0.8% | 0.1% |
| Failure to auto stop | 2 | 0.8% | 0.1% |
| Failure to shut off | 2 | 0.8% | 1.3% |
| Inappropriate/inadequate shock/stimulation | 2 | 0.8% | 0.6% |
| Material frayed | 2 | 0.8% | 0% |
| Burst container or vessel | 1 | 0.4% | 0.2% |
| Device displays incorrect message | 1 | 0.4% | 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 |
|---|---|---|
| Partial thickness (second degree) burn | 83 | 33.1% |
| Burn, thermal | 50 | 19.9% |
| Full thickness (third degree) burn | 46 | 18.3% |
| Burn(s)a burn | 43 | 17.1% |
| Scarring | 5 | 2% |
| Superficial (first degree) burn | 5 | 2% |
| Swellingswelling | 5 | 2% |
| Electric shockan electric shock | 4 | 1.6% |
| Erythemaskin redness | 2 | 0.8% |
| Hemorrhage/blood loss/bleeding | 2 | 0.8% |
| Laceration(s) | 2 | 0.8% |
| Skin discoloration | 2 | 0.8% |
| Blurred vision | 1 | 0.4% |
| Chest painchest pain | 1 | 0.4% |
| Corneal abrasion | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Softheat | Product code IRT | All MAUDE reports |
|---|---|---|---|
| Reports | 251 | 6,882 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 4 | 2 | 9 |
| Classified as injury | 33.9% | 21% | 36.2% |
| Classified as malfunction | 1.6% | 70.1% | 62.3% |
| Filed by the manufacturer | 99.2% | 91.2% | 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 IRT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Thermophore | 1,970 | 0 | 0.1% |
| Thermophore Automatic Moist Heat Pack | 1,321 | 0 | 0% |
| Sunbeam | 1,502 | 29 | 0.4% |
| Thermophore Automatic Heat Pack | 305 | 0 | 0% |
| Thermophore Arthritis Pad | 272 | 0 | 0% |
| Mighty Bliss | 250 | 0 | 0% |
| Conair | 312 | 10 | 0% |
| Conmed | 900 | 89 | 0.2% |
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 Softheat reports
How many FDA reports name Softheat?
251 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?
other (64.1%), injury (33.9%) and malfunction (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
improper or incorrect procedure or method (57.8%), insufficient device problem information (10.8%), overheating of device (5.2%), device operates differently than expected (4.4%) and fire (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Softheat 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.