Devices › Vehicle, motorized 3-wheeled
Device brand name
Motorized 3-Wheeled Vehicle For Outside Transport: medical device reports filed with FDA
1,044 reports name it, 2011–2014. Manufacturer given most often on reports: C T M Homecare Product. Product code INI.
- 1,044
- device reports naming the brand
- 0% of all MAUDE reports · about 69 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 12.5%
- classified as malfunction
- 22.9% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,044 medical device reports received by FDA name the brand "Motorized 3-Wheeled Vehicle For Outside Transport"; the manufacturer given most often on reports is C T M Homecare Product; received from June 2011 to November 2014. 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 (12.5%) and death (0.1%); across all vehicle, motorized 3-wheeled reports (product code INI) death is recorded in 2.7% and malfunction in 22.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are product quality problem (15.7%), device stops intermittently (13.3%) and break (12.6%). The patient problems coded most often are fall, injury and bruise/contusion. 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 Motorized 3-Wheeled Vehicle For Outside Transport was received in the five years to August 2026; the latest was received in November 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,720 reports carrying product code INI. 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 |
|---|---|---|---|
| Product quality problem | 164 | 15.7% | 6.4% |
| Device stops intermittentlythe device stopped now and then | 139 | 13.3% | 5.8% |
| Breakthe device broke | 132 | 12.6% | 7.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 119 | 11.4% | 6% |
| Unintended movement | 105 | 10.1% | 4.9% |
| Unstable | 86 | 8.2% | 4.3% |
| Device inoperablethe device could not be used | 58 | 5.6% | 3.1% |
| Battery problema problem with the battery | 27 | 2.6% | 1.1% |
| Detachment of device component | 23 | 2.2% | 2.2% |
| Device tipped over | 23 | 2.2% | 8% |
| Crackthe device cracked | 19 | 1.8% | 2.6% |
| Electronic property issue | 19 | 1.8% | 0.7% |
| Loss of powerthe device lost power | 15 | 1.4% | 1.7% |
| Overheating of device | 14 | 1.3% | 0.6% |
| Bent | 13 | 1.2% | 0.5% |
| Device displays incorrect message | 13 | 1.2% | 0.6% |
| Naturally worn | 12 | 1.1% | 0.5% |
| Insufficient device problem information | 9 | 0.9% | 1.6% |
| Melted | 9 | 0.9% | 0.5% |
| Thermal decomposition of device | 9 | 0.9% | 0.6% |
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 |
|---|---|---|
| Falla fall | 44 | 4.2% |
| Injurya physical injury | 14 | 1.3% |
| Bruise/contusion | 12 | 1.1% |
| Discomfortdiscomfort | 7 | 0.7% |
| Skin tears | 6 | 0.6% |
| Abrasion | 5 | 0.5% |
| Bone fracture(s) | 5 | 0.5% |
| Laceration(s) | 2 | 0.2% |
| Sprain | 2 | 0.2% |
| Crushing injury | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Heartburn/indigestion | 1 | 0.1% |
| Lymphomaa cancer of the lymphatic system | 1 | 0.1% |
| No patient involvement | 1 | 0.1% |
| Paraplegia | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Motorized 3-Wheeled Vehicle For Outside Transport | Product code INI | All MAUDE reports |
|---|---|---|---|
| Reports | 1,044 | 2,720 | 26,136,888 |
| Share of that pool | — | 38.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 27 | 9 |
| Classified as injury | 0% | 33.3% | 36.2% |
| Classified as malfunction | 12.5% | 22.9% | 62.3% |
| Filed by the manufacturer | 100% | 89.6% | 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 INI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pride Mobility Products | 1,939 | 145 | 3.6% |
| Rascal | 555 | 0 | 2.2% |
| Pride | 464 | 0 | 10.1% |
| Hoveround Corporation | 296 | 0 | 8.1% |
| Drive | 701 | 20 | 4.4% |
| Drive Medical | 290 | 0 | 10% |
| Mechanical Chair/Transport Chair | 1,248 | 0 | 0.2% |
| Sterling | 4,963 | 300 | 0.1% |
| Hoveround | 154 | 1 | 5.8% |
| Sftwr Css7201 Guardian Android App | 955 | 2 | 0% |
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 Motorized 3-Wheeled Vehicle For Outside Transport reports
How many FDA reports name Motorized 3-Wheeled Vehicle For Outside Transport?
1,044 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 (12.5%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
product quality problem (15.7%), device stops intermittently (13.3%), break (12.6%), device operates differently than expected (11.4%) and unintended movement (10.1%). 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 Motorized 3-Wheeled Vehicle For Outside Transport 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.