Reported Reactions

Devices › Walker, mechanical

Device brand name · Walker mechanical

Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547: medical device reports filed with FDA

169 reports name it, 2014–2015. Manufacturer given most often on reports: Danyang Maxthai Medical Equipment. Product code ITJ.

169
device reports naming the brand
0% of all MAUDE reports · about 15 a year
0
reports, 12 months to August 2026
0 in the 12 months before
96.4%
classified as malfunction
54.4% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 169 reports that name the brand "Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547" (walker mechanical), received between December 2014 and September 2015; the manufacturer given most often on reports is Danyang Maxthai Medical Equipment. 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 (96.4%) and injury (3.6%); across all walker, mechanical reports (product code ITJ) death is recorded in 0.3% and malfunction in 54.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are unstable (37.9%), break (29.6%) and product quality problem (7.7%). The patient problems coded most often are fall, abrasion and bone fracture(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 Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547 was received in the five years to August 2026; the latest was received in September 2015.

Event type and report source

Event type, as classified on the report

Death0%0
Injury3.6%6
Malfunction96.4%163
Other0%0
Not given0%0

Who filed the report

Manufacturer report0.6%1
Voluntary report0%0
User facility report0%0
Distributor report99.4%168
Not given0%0

Grey bar: all 15,177 reports carrying product code ITJ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Unstable6437.9%13.3%
Breakthe device broke5029.6%22.6%
Product quality problem137.7%4.8%
Bent116.5%2.9%
Detachment of device component95.3%4.2%
Mechanical jam84.7%1.4%
Out-of-box failure84.7%0.7%
Unintended movement84.7%1.1%
Deformation due to compressive stress74.1%0.3%
Crackthe device cracked63.6%4.2%
Naturally worn63.6%1.1%
Device inoperablethe device could not be used42.4%0.7%
Bolus mechanism failure21.2%0%
Collapse10.6%1.4%
Device operates differently than expectedthe device behaved unexpectedly10.6%2.2%
Material disintegration10.6%0%
Material separation10.6%0.8%

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 fall53%
Abrasion10.6%
Bone fracture(s)10.6%
Discomfortdiscomfort10.6%
Urinary retentionbeing unable to empty the bladder10.6%

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

In context

MeasureEconomy Rollator W/Hand Brake W/Curve Bkrst 9153644547Product code ITJAll MAUDE reports
Reports16915,17726,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports039
Classified as injury3.6%10.5%36.2%
Classified as malfunction96.4%54.4%62.3%
Filed by the manufacturer0.6%87.5%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 ITJ

BrandReportsLatest 12 monthsClassified as death
Mechanical Walker Rollator5,68100%
Medline26,93526,1840.1%
Rollator 915365131582600%
Drive701204.4%
Guardian5573500.4%
Drive Medical290010%
Mechanical Manual Wheelchair10,27900%
Transport 20 In X 16 In 91536375741,97300.1%
Daily Activity Assist Devices3,38500%
Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back60800%
Invacare200017%
Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 915364940328500%
Powered Wheelchair18,46400.1%
Donjoy16430%
Invacare Power Wheelchair24805.2%

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 Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547 reports

How many FDA reports name Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547?

169 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 (96.4%) and injury (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

unstable (37.9%), break (29.6%), product quality problem (7.7%), bent (6.5%) and detachment of device component (5.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

distributor reports (99.4%) and manufacturer reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547 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.