Devices › Wheelchair, mechanical
Device brand name · Wheelchair
Mechanical Manual Wheelchair: medical device reports filed with FDA
10,279 reports name it, 2008–2014. Manufacturer given most often on reports: Invamex. Product code IOR.
- 10,279
- device reports naming the brand
- 0% of all MAUDE reports · about 579 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 82.3%
- classified as malfunction
- 89.3% across the product code
- 0%
- classified as death, as reported
- 3 reports · not verified by FDA
10,279 medical device reports received by FDA name the brand "Mechanical Manual Wheelchair" (wheelchair); the manufacturer given most often on reports is Invamex; received from October 2008 to December 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 (82.3%) and injury (0.8%); across all wheelchair, mechanical reports (product code IOR) death is recorded in 0.2% and malfunction in 89.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (45.4%), bent (9.5%) and device operates differently than expected (7.8%). The patient problems coded most often are fall, injury and laceration(s). 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 Mechanical Manual Wheelchair was received in the five years to August 2026; the latest was received in December 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 28,715 reports carrying product code IOR. 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 |
|---|---|---|---|
| Breakthe device broke | 4,668 | 45.4% | 29.9% |
| Bent | 973 | 9.5% | 6.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 800 | 7.8% | 4.7% |
| Detachment of device component | 784 | 7.6% | 4.5% |
| Crackthe device cracked | 554 | 5.4% | 4.1% |
| Device slipped | 476 | 4.6% | 2.9% |
| Mechanical problema mechanical problem | 332 | 3.2% | 3.9% |
| Unstable | 307 | 3% | 2.1% |
| Product quality problem | 263 | 2.6% | 1.1% |
| Torn material | 222 | 2.2% | 1.5% |
| Naturally worn | 208 | 2% | 1.5% |
| Component falling | 168 | 1.6% | 1.3% |
| Component missing | 124 | 1.2% | 1.3% |
| Material integrity problema problem with the device material | 122 | 1.2% | 1% |
| Sticking | 116 | 1.1% | 0.7% |
| Loose or intermittent connection | 109 | 1.1% | 1.4% |
| Device inoperablethe device could not be used | 86 | 0.8% | 0.5% |
| Peeled/delaminated | 84 | 0.8% | 0.4% |
| Mechanics altered | 71 | 0.7% | 0.8% |
| Material separation | 68 | 0.7% | 1.1% |
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 |
|---|---|---|
| Falla fall | 184 | 1.8% |
| Injurya physical injury | 123 | 1.2% |
| Laceration(s) | 50 | 0.5% |
| Bruise/contusion | 40 | 0.4% |
| Painpain, site not specified | 21 | 0.2% |
| Discomfortdiscomfort | 18 | 0.2% |
| Bone fracture(s) | 15 | 0.1% |
| Skin tears | 14 | 0.1% |
| No patient involvement | 12 | 0.1% |
| Swellingswelling | 11 | 0.1% |
| Abrasion | 9 | 0.1% |
| Head injurya head injury | 9 | 0.1% |
| Physical entrapment | 8 | 0.1% |
| Pressure sore/ulcer | 8 | 0.1% |
| Hemorrhage/blood loss/bleeding | 4 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mechanical Manual Wheelchair | Product code IOR | All MAUDE reports |
|---|---|---|---|
| Reports | 10,279 | 28,715 | 26,136,888 |
| Share of that pool | — | 35.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.8% | 3.7% | 36.2% |
| Classified as malfunction | 82.3% | 89.3% | 62.3% |
| Filed by the manufacturer | 100% | 96% | 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 IOR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quickie 2 Wheelchair | 3,756 | 0 | 0% |
| Medline | 26,935 | 26,184 | 0.1% |
| Transport 20 In X 16 In 9153637574 | 1,973 | 0 | 0.1% |
| Quickie | 1,619 | 1 | 0.2% |
| Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back | 608 | 0 | 0% |
| 9xt Swingaway Frame Style 9153629153 | 368 | 0 | 0% |
| Tracer Transport Chair 19 X 16 9153647029 | 342 | 0 | 0% |
| Breezy Wheelchair | 334 | 0 | 0% |
| Quickie Rx Wheelchair | 320 | 0 | 0% |
| Quickie Revolution Wheelchair | 311 | 0 | 0% |
| T4/Wd28/Hd/Adult/18/Bh16/At903/U2222c/U67 9153653569 | 293 | 0 | 0% |
| Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 9153649403 | 285 | 0 | 0% |
| Trex2/Wd06/18/Bh16/U2222c/Adult/U67/1255 9153653553 | 198 | 0 | 0% |
| Solara 3g Ltd 20w 24 Com 9153653250 | 168 | 0 | 0% |
| Non-Folding Device 9153645342 | 151 | 0 | 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 Mechanical Manual Wheelchair reports
How many FDA reports name Mechanical Manual Wheelchair?
10,279 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 (82.3%) and injury (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (45.4%), bent (9.5%), device operates differently than expected (7.8%), detachment of device component (7.6%) and crack (5.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and distributor reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mechanical Manual Wheelchair 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.