Devices › Pack, hot or cold, disposable
Device brand name · Disposable pack hot
Thermacare Neck Shoulder & Wrist: medical device reports filed with FDA
288 reports name it, 2015–2021. Manufacturer given most often on reports: Pfizer Consumer Health Care. Product code IMD.
- 288
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 19.1%
- classified as malfunction
- 23.5% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
288 medical device reports received by FDA name the brand "Thermacare Neck Shoulder & Wrist" (disposable pack hot); the manufacturer given most often on reports is Pfizer Consumer Health Care; received from February 2015 to March 2021. 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 injury (80.2%), malfunction (19.1%) and death (0.3%); 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 (11.8%), leak/splash (11.8%) and insufficient device problem information (10.8%). 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
No report naming Thermacare Neck Shoulder & Wrist was received in the five years to August 2026; the latest was received in March 2021.
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 | 34 | 11.8% | 6.7% |
| Leak/splashthe device leaked | 34 | 11.8% | 7.4% |
| Insufficient device problem information | 31 | 10.8% | 14.2% |
| Overheating of device | 20 | 6.9% | 2.8% |
| Patient-device incompatibilitythe device did not suit the patient | 17 | 5.9% | 2.3% |
| Temperature problem | 15 | 5.2% | 2.1% |
| Breakthe device broke | 14 | 4.9% | 2.2% |
| Insufficient heating | 10 | 3.5% | 0.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 3.1% | 2% |
| Loss of or failure to bond | 7 | 2.4% | 0.5% |
| Defective devicethe device was defective | 5 | 1.7% | 1% |
| Excessive heating | 5 | 1.7% | 2% |
| Material protrusion/extrusion | 5 | 1.7% | 0.2% |
| Unintended ejection | 5 | 1.7% | 0.9% |
| Material deformation | 4 | 1.4% | 0.4% |
| Physical resistance/sticking | 4 | 1.4% | 0.2% |
| Difficult to removethe device was hard to remove | 3 | 1% | 1.4% |
| Failure to adhere or bond | 3 | 1% | 0.2% |
| Nonstandard device | 3 | 1% | 1.9% |
| Product quality problem | 3 | 1% | 0.8% |
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 | 111 | 38.5% |
| Burn, thermal | 72 | 25% |
| Painpain, site not specified | 51 | 17.7% |
| Swellingswelling | 30 | 10.4% |
| Erythemaskin redness | 27 | 9.4% |
| Itching sensation | 18 | 6.3% |
| Scarring | 14 | 4.9% |
| Injurya physical injury | 13 | 4.5% |
| Rashskin rash | 10 | 3.5% |
| Skin irritationirritated skin | 9 | 3.1% |
| Tissue damage | 6 | 2.1% |
| Burning sensationa burning feeling | 5 | 1.7% |
| Discomfortdiscomfort | 5 | 1.7% |
| Full thickness (third degree) burn | 5 | 1.7% |
| Abrasion | 4 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Thermacare Neck Shoulder & Wrist | Product code IMD | All MAUDE reports |
|---|---|---|---|
| Reports | 288 | 4,430 | 26,136,888 |
| Share of that pool | — | 6.5% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 80.2% | 50.3% | 36.2% |
| Classified as malfunction | 19.1% | 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 Lower Back & Hip | 720 | 9 | 0.4% |
| 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 Neck Shoulder & Wrist reports
How many FDA reports name Thermacare Neck Shoulder & Wrist?
288 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?
injury (80.2%), malfunction (19.1%) and death (0.3%). "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 (11.8%), leak/splash (11.8%), insufficient device problem information (10.8%), overheating of device (6.9%) and patient-device incompatibility (5.9%). 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 Neck Shoulder & Wrist 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.