Devices › Pack, hot or cold, disposable
Device brand name · Imd
Icy Hot Heat Therapy Patch: medical device reports filed with FDA
842 reports name it, 2007–2010. Manufacturer given most often on reports: Chattem. Product code IMD.
- 842
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 23.5% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
842 medical device reports received by FDA name the brand "Icy Hot Heat Therapy Patch" (imd); the manufacturer given most often on reports is Chattem; received from March 2007 to March 2010. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (99.5%), injury (0.4%) and death (0.1%); across all pack, hot or cold, disposable reports (product code IMD) death is recorded in 0.2% and malfunction in 23.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (12.7%), difficult to remove (4.8%) and nonstandard device (1%). The patient problems coded most often are burn, thermal, treatment with medication(s) and skin tears. 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 Icy Hot Heat Therapy Patch was received in the five years to August 2026; the latest was received in March 2010.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,430 reports carrying product code IMD. 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 |
|---|---|---|---|
| Insufficient device problem information | 107 | 12.7% | 14.2% |
| Difficult to removethe device was hard to remove | 40 | 4.8% | 1.4% |
| Nonstandard device | 8 | 1% | 1.9% |
| Overheating of device | 3 | 0.4% | 2.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.2% | 2% |
| Device, removal of (non-implant) | 2 | 0.2% | 0.2% |
| Heat | 2 | 0.2% | 0.2% |
| Sticking | 2 | 0.2% | 0.1% |
| Breakthe device broke | 1 | 0.1% | 2.2% |
| Fluid/blood leak | 1 | 0.1% | 2.7% |
| Improper or incorrect procedure or method | 1 | 0.1% | 6.7% |
| Labelling, instructions for use or training problem | 1 | 0.1% | 0.2% |
| Leak/splashthe device leaked | 1 | 0.1% | 7.4% |
| Thermal decomposition of device | 1 | 0.1% | 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 |
|---|---|---|
| Burn, thermal | 487 | 57.8% |
| Treatment with medication(s) | 333 | 39.5% |
| Skin tears | 290 | 34.4% |
| Blister(s) | 198 | 23.5% |
| Erythemaskin redness | 158 | 18.8% |
| Therapy/non-surgical treatment, additional | 156 | 18.5% |
| Scarring | 117 | 13.9% |
| Painpain, site not specified | 85 | 10.1% |
| Scar tissue | 41 | 4.9% |
| Burning sensationa burning feeling | 30 | 3.6% |
| Hospitalization required | 29 | 3.4% |
| Skin erosion | 29 | 3.4% |
| Irritationirritation | 27 | 3.2% |
| Itching sensation | 24 | 2.9% |
| Soreness | 24 | 2.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Icy Hot Heat Therapy Patch | Product code IMD | All MAUDE reports |
|---|---|---|---|
| Reports | 842 | 4,430 | 26,136,888 |
| Share of that pool | — | 19% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 0.4% | 50.3% | 36.2% |
| Classified as malfunction | 0% | 23.5% | 62.3% |
| Filed by the manufacturer | 99.4% | 82% | 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 IMD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Thermacare Lower Back & Hip | 720 | 9 | 0.4% |
| Thermacare Neck Shoulder & Wrist | 288 | 0 | 0.3% |
| Thermacare Menstrual | 215 | 4 | 0% |
| Thermacare Heatwrap | 162 | 0 | 0.6% |
| Cardinal Health | 589 | 185 | 0.2% |
| Sunbeam | 1,502 | 29 | 0.4% |
| McKesson Brands | 397 | 75 | 0% |
| Novation | 235 | 23 | 0.4% |
| Thermophore | 1,970 | 0 | 0.1% |
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 Icy Hot Heat Therapy Patch reports
How many FDA reports name Icy Hot Heat Therapy Patch?
842 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 (99.5%), injury (0.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (12.7%), difficult to remove (4.8%), nonstandard device (1%), overheating of device (0.4%) and device operates differently than expected (0.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Icy Hot Heat Therapy Patch 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.