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Device brand name · Disposable pack hot
Thermacare Lower Back & Hip: medical device reports filed with FDA
720 reports name it, 2012–2026. Manufacturer given most often on reports: Pfizer Consumer Health Care. Product code IMD.
- 720
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 9
- reports, 12 months to August 2026
- 12 in the 12 months before
- 13.5%
- classified as malfunction
- 23.5% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 720 reports that name the brand "Thermacare Lower Back & Hip" (disposable pack hot), received between January 2012 and June 2026; the manufacturer given most often on reports is Pfizer Consumer Health Care. Spellings of one product vary from report to report.
9 reports arrived in the 12 months to August 2026, down 25% from 12 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 (84.9%), malfunction (13.5%) and other (1.3%); 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 improper or incorrect procedure or method (16.4%), insufficient device problem information (11.1%) and leak/splash (8.3%). The patient problems coded most often are partial thickness (second degree) burn, burn, thermal and pain. 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 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 |
|---|---|---|---|
| Improper or incorrect procedure or method | 118 | 16.4% | 6.7% |
| Insufficient device problem information | 80 | 11.1% | 14.2% |
| Leak/splashthe device leaked | 60 | 8.3% | 7.4% |
| Overheating of device | 41 | 5.7% | 2.8% |
| Patient-device incompatibilitythe device did not suit the patient | 37 | 5.1% | 2.3% |
| Breakthe device broke | 26 | 3.6% | 2.2% |
| Temperature problem | 26 | 3.6% | 2.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 3.5% | 2% |
| Excessive heating | 22 | 3.1% | 2% |
| Defective devicethe device was defective | 18 | 2.5% | 1% |
| Nonstandard device | 15 | 2.1% | 1.9% |
| Unintended ejection | 11 | 1.5% | 0.9% |
| Product quality problem | 10 | 1.4% | 0.8% |
| Insufficient heating | 9 | 1.3% | 0.9% |
| Loss of or failure to bond | 7 | 1% | 0.5% |
| Therapeutic or diagnostic output failure | 6 | 0.8% | 0.3% |
| Unexpected therapeutic results | 5 | 0.7% | 0.2% |
| Device markings/labelling problema problem with the device markings or label | 4 | 0.6% | 0.2% |
| Expiration date error | 4 | 0.6% | 0.1% |
| Material deformation | 4 | 0.6% | 0.4% |
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 | 309 | 42.9% |
| Burn, thermal | 227 | 31.5% |
| Painpain, site not specified | 132 | 18.3% |
| Swellingswelling | 65 | 9% |
| Erythemaskin redness | 47 | 6.5% |
| Scarring | 38 | 5.3% |
| Itching sensation | 30 | 4.2% |
| Rashskin rash | 30 | 4.2% |
| Burning sensationa burning feeling | 28 | 3.9% |
| Full thickness (third degree) burn | 25 | 3.5% |
| Discomfortdiscomfort | 24 | 3.3% |
| Skin irritationirritated skin | 24 | 3.3% |
| Burn(s)a burn | 20 | 2.8% |
| Injurya physical injury | 13 | 1.8% |
| Superficial (first degree) burn | 12 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Thermacare Lower Back & Hip | Product code IMD | All MAUDE reports |
|---|---|---|---|
| Reports | 720 | 4,430 | 26,136,888 |
| Share of that pool | — | 16.3% | 0% |
| Classified as death, per 1,000 reports | 4 | 2 | 9 |
| Classified as injury | 84.9% | 50.3% | 36.2% |
| Classified as malfunction | 13.5% | 23.5% | 62.3% |
| Filed by the manufacturer | 100% | 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 |
|---|---|---|---|
| Icy Hot Heat Therapy Patch | 842 | 0 | 0.1% |
| 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 Thermacare Lower Back & Hip reports
How many FDA reports name Thermacare Lower Back & Hip?
720 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (84.9%), malfunction (13.5%) and other (1.3%). "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 (16.4%), insufficient device problem information (11.1%), leak/splash (8.3%), overheating of device (5.7%) and patient-device incompatibility (5.1%). 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 Thermacare Lower Back & Hip 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.