Reported Reactions

Devices › Wheelchair, mechanical

Device brand name · Wheelchair mechanical

Breezy Wheelchair: medical device reports filed with FDA

334 reports name it, 1996–2000. Manufacturer given most often on reports: Sunrise Medical Mpd. Product code IOR.

334
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
100%
classified as malfunction
89.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 334 reports that name the brand "Breezy Wheelchair" (wheelchair mechanical), received between September 1996 and March 2000; the manufacturer given most often on reports is Sunrise Medical Mpd. 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 (100%); 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 component(s), broken (41.3%), fracture (4.2%) and break (2.7%). The patient problems coded most often are fall and injury. 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 Breezy Wheelchair was received in the five years to August 2026; the latest was received in March 2000.

By year received

0591181996: 3019961997: 10119971998: 11819981999: 7819992000: 72000

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%334
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%334
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Component(s), broken13841.3%8.8%
Fracturea broken bone144.2%5.2%
Breakthe device broke92.7%29.9%
Crackthe device cracked92.7%4.1%
Other (for use when an appropriate device code cannot be identified)20.6%0.3%
Detachment of device component10.3%4.5%
Device issuea problem with the device10.3%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)ReportsShare
Falla fall20.6%
Injurya physical injury20.6%

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

In context

MeasureBreezy WheelchairProduct code IORAll MAUDE reports
Reports33428,71526,136,888
Share of that pool—1.2%0%
Classified as death, per 1,000 reports029
Classified as injury0%3.7%36.2%
Classified as malfunction100%89.3%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Mechanical Manual Wheelchair10,27900%
Quickie 2 Wheelchair3,75600%
Medline26,93526,1840.1%
Transport 20 In X 16 In 91536375741,97300.1%
Quickie1,61910.2%
Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back60800%
9xt Swingaway Frame Style 915362915336800%
Tracer Transport Chair 19 X 16 915364702934200%
Quickie Rx Wheelchair32000%
Quickie Revolution Wheelchair31100%
T4/Wd28/Hd/Adult/18/Bh16/At903/U2222c/U67 915365356929300%
Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 915364940328500%
Trex2/Wd06/18/Bh16/U2222c/Adult/U67/1255 915365355319800%
Solara 3g Ltd 20w 24 Com 915365325016800%
Non-Folding Device 915364534215100%

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 Breezy Wheelchair reports

How many FDA reports name Breezy Wheelchair?

334 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

component(s), broken (41.3%), fracture (4.2%), break (2.7%), crack (2.7%) and other (for use when an appropriate device code cannot be identified) (0.6%). 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 Breezy 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.