Devices › System, thermal regulating
Device brand name · Arctic sun gel pads
Arcticgel Pads: medical device reports filed with FDA
322 reports name it, 2015–2023. Manufacturer given most often on reports: Productos Para El Cuidado De La Salud -9611590. Product code DWJ.
- 322
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.8%
- classified as malfunction
- 90.9% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
322 medical device reports received by FDA name the brand "Arcticgel Pads" (arctic sun gel pads); the manufacturer given most often on reports is Productos Para El Cuidado De La Salud -9611590; received from October 2015 to November 2023. 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 malfunction (88.8%), injury (10.9%) and death (0.3%); 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 inaccurate flow rate (28%), insufficient flow or under infusion (18.6%) and device displays incorrect message (10.9%). The patient problems coded most often are alteration in body temperature, death 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
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 |
|---|---|---|---|
| Inaccurate flow rate | 90 | 28% | 9.2% |
| Insufficient flow or under infusion | 60 | 18.6% | 1.2% |
| Device displays incorrect message | 35 | 10.9% | 5.6% |
| Air leak | 29 | 9% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 23 | 7.1% | 2.2% |
| Temperature problem | 22 | 6.8% | 6.9% |
| Restricted flow rate | 21 | 6.5% | 5.6% |
| Improper flow or infusion | 18 | 5.6% | 0.4% |
| Leak/splashthe device leaked | 17 | 5.3% | 0.8% |
| Infusion or flow problema problem with flow or infusion | 14 | 4.3% | 1% |
| No flow | 14 | 4.3% | 1.1% |
| Display or visual feedback problem | 10 | 3.1% | 0.7% |
| Gas/air leak | 9 | 2.8% | 6% |
| Insufficient device problem information | 9 | 2.8% | 1.2% |
| Output below specifications | 9 | 2.8% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 6 | 1.9% | 0.4% |
| Material separation | 5 | 1.6% | 0.4% |
| Breakthe device broke | 4 | 1.2% | 0.5% |
| Therapeutic or diagnostic output failure | 4 | 1.2% | 0.7% |
| Connection problema connection problem | 3 | 0.9% | 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 |
|---|---|---|
| Alteration in body temperature | 24 | 7.5% |
| Deaththe patient died; cause not stated by this term | 15 | 4.7% |
| Skin tears | 8 | 2.5% |
| Injurya physical injury | 6 | 1.9% |
| Cardiac arrestthe heart stopped | 5 | 1.6% |
| Hypothermia | 4 | 1.2% |
| Erythemaskin redness | 3 | 0.9% |
| No patient involvement | 3 | 0.9% |
| Partial thickness (second degree) burn | 3 | 0.9% |
| Tissue damage | 3 | 0.9% |
| Brain injury | 2 | 0.6% |
| Inadequate pain relief | 2 | 0.6% |
| Peeling | 2 | 0.6% |
| Shaking/tremors | 2 | 0.6% |
| Bruise/contusion | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Arcticgel Pads | Product code DWJ | All MAUDE reports |
|---|---|---|---|
| Reports | 322 | 26,725 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 10.9% | 8.2% | 36.2% |
| Classified as malfunction | 88.8% | 90.9% | 62.3% |
| Filed by the manufacturer | 99.4% | 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% |
| Bair Hugger | 408 | 1 | 2.2% |
| 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 Arcticgel Pads reports
How many FDA reports name Arcticgel Pads?
322 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?
malfunction (88.8%), injury (10.9%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inaccurate flow rate (28%), insufficient flow or under infusion (18.6%), device displays incorrect message (10.9%), air leak (9%) and device operates differently than expected (7.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Arcticgel Pads 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.