Reported Reactions

Devices › Wheelchair, powered

Device brand name · Wheelchair powered

Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box: medical device reports filed with FDA

1,309 reports name it, 2014–2016. Manufacturer given most often on reports: Invacare Taylor Street. Product code ITI.

1,309
device reports naming the brand
0% of all MAUDE reports · about 113 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98.9%
classified as malfunction
87.6% across the product code
0.2%
classified as death, as reported
3 reports · not verified by FDA

FDA's MAUDE database holds 1,309 reports that name the brand "Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box" (wheelchair powered), received between December 2014 and September 2016; the manufacturer given most often on reports is Invacare Taylor Street. Spellings of one product vary from report to report.

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 (98.9%), injury (0.8%) and death (0.2%); across all wheelchair, powered reports (product code ITI) death is recorded in 0.6% and malfunction in 87.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device operates differently than expected (21.4%), break (14.7%) and mechanical problem (9.6%). The patient problems coded most often are injury, bone fracture(s) and fall. 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 Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box was received in the five years to August 2026; the latest was received in September 2016.

By year received

04428832014: 8820142015: 88320152016: 3382016

Event type and report source

Event type, as classified on the report

Death0.2%3
Injury0.8%10
Malfunction98.9%1,294
Other0%0
Not given0.2%2

Who filed the report

Manufacturer report100%1,309
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 30,586 reports carrying product code ITI. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device operates differently than expectedthe device behaved unexpectedly28021.4%17.6%
Breakthe device broke19314.7%12.5%
Mechanical problema mechanical problem1269.6%6.6%
Bent796%3.4%
Device stops intermittentlythe device stopped now and then705.3%2.8%
Loss of powerthe device lost power644.9%3%
Device displays incorrect message614.7%3%
Device inoperablethe device could not be used584.4%3.6%
Failure to shut off524%4.6%
Leak/splashthe device leaked493.7%5.1%
Sticking463.5%3.4%
Device slipped453.4%3.2%
Unintended movement382.9%2.8%
Crackthe device cracked362.8%1.6%
Self-activation or keying282.1%2.2%
Detachment of device component272.1%3.1%
Failure to power up262%0.8%
Noise, audible262%1.7%
Loose or intermittent connection231.8%0.9%
Smoking201.5%1.2%

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)ReportsShare
Injurya physical injury100.8%
Bone fracture(s)50.4%
Falla fall50.4%
Complaint, ill-defined40.3%
Bruise/contusion30.2%
Deaththe patient died; cause not stated by this term20.2%
No patient involvement20.2%
Abrasion10.1%
Alteration in body temperature10.1%
Brain injury10.1%
Edemaswelling from fluid10.1%
Head injurya head injury10.1%
Hematomaa collection of blood under the skin or in tissue10.1%
Hemorrhage/blood loss/bleeding10.1%
Laceration(s)10.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear BoxProduct code ITIAll MAUDE reports
Reports1,30930,58626,136,888
Share of that pool—4.3%0%
Classified as death, per 1,000 reports269
Classified as injury0.8%9.8%36.2%
Classified as malfunction98.9%87.6%62.3%
Filed by the manufacturer100%98.7%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 ITI

BrandReportsLatest 12 monthsClassified as death
Powered Wheelchair18,46400.1%
Power Chair 20 Wide By 18 Deep For Pmi3,20200%
Pride Mobility Products1,9391453.6%
SmartDrive9326620%
M51p Blue Base W/Mk5 Nx Spj+ 915364208739500%
Quickie1,61910.2%
Tdxsp Wet Black Euro Narrow Base W/ 23-1 Ssd Gear Box27000%
Invacare Power Wheelchair24805.2%
Pride464010.1%
Hoveround Corporation29608.1%
Pronto M41 Blue Base 915364576218500%
M51p Red Base W/Mk5 Nx Spj+ 915364208818100%
Tdxsp Wet Black Euro Narrow Base W/ 18-1 Ssd Gear Box17600%
Hoveround15415.8%
Pronto M6115200%

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 Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box reports

How many FDA reports name Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box?

1,309 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 (98.9%), injury (0.8%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device operates differently than expected (21.4%), break (14.7%), mechanical problem (9.6%), bent (6%) and device stops intermittently (5.3%). 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 Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box 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.