Device brand name · Rollator
Drive Medical: medical device reports filed with FDA
290 reports name it, 2007–2023. Manufacturer given most often on reports: Fort Metal Plastic. Product code ITJ.
- 290
- 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
- 5.2%
- classified as malfunction
- 54.4% across the product code
- 10%
- classified as death, as reported
- 29 reports · not verified by FDA
FDA's MAUDE database holds 290 reports that name the brand "Drive Medical" (rollator), received between June 2007 and December 2023; the manufacturer given most often on reports is Fort Metal Plastic. 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 injury (82.8%), death (10%) and malfunction (5.2%); 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 break (8.3%), collapse (8.3%) and detachment of device component (6.9%). The patient problems coded most often are fall, bone fracture(s) 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 24 | 8.3% | 22.6% |
| Collapse | 24 | 8.3% | 1.4% |
| Detachment of device component | 20 | 6.9% | 4.2% |
| Insufficient device problem information | 17 | 5.9% | 1.1% |
| Detachment of device or device componentpart of the device came off | 15 | 5.2% | 2.2% |
| Component(s), broken | 13 | 4.5% | 0.5% |
| Device tipped over | 12 | 4.1% | 0.4% |
| Bent | 11 | 3.8% | 2.9% |
| Improper or incorrect procedure or method | 9 | 3.1% | 0.2% |
| Fracturea broken bone | 7 | 2.4% | 12.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 2.1% | 2.2% |
| Unable to confirm conditions of use | 6 | 2.1% | 0% |
| Component falling | 5 | 1.7% | 0.8% |
| Device maintenance issue | 5 | 1.7% | 0% |
| Device issuea problem with the device | 4 | 1.4% | 0.1% |
| Fire | 4 | 1.4% | 0% |
| Material integrity problema problem with the device material | 4 | 1.4% | 0.7% |
| Mechanical problema mechanical problem | 4 | 1.4% | 2.9% |
| Unintended movement | 4 | 1.4% | 1.1% |
| Device slipped | 3 | 1% | 3.1% |
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 | 136 | 46.9% |
| Bone fracture(s) | 66 | 22.8% |
| Injurya physical injury | 58 | 20% |
| Deaththe patient died; cause not stated by this term | 23 | 7.9% |
| Hip fracturea broken hip | 16 | 5.5% |
| Laceration(s) | 16 | 5.5% |
| Bruise/contusion | 11 | 3.8% |
| Fracture, arm | 8 | 2.8% |
| Head injurya head injury | 6 | 2.1% |
| Burn(s)a burn | 5 | 1.7% |
| Contusiona bruise | 5 | 1.7% |
| Crushing injury | 5 | 1.7% |
| Cut(s) | 4 | 1.4% |
| Hospitalization required | 4 | 1.4% |
| Physical entrapment | 4 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Drive Medical | Product code ITJ | All MAUDE reports |
|---|---|---|---|
| Reports | 290 | 15,177 | 26,136,888 |
| Share of that pool | — | 1.9% | 0% |
| Classified as death, per 1,000 reports | 100 | 3 | 9 |
| Classified as injury | 82.8% | 10.5% | 36.2% |
| Classified as malfunction | 5.2% | 54.4% | 62.3% |
| Filed by the manufacturer | 10% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mechanical Walker Rollator | 5,681 | 0 | 0% |
| Medline | 26,935 | 26,184 | 0.1% |
| Rollator 9153651315 | 826 | 0 | 0% |
| Drive | 701 | 20 | 4.4% |
| Guardian | 557 | 350 | 0.4% |
| Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547 | 169 | 0 | 0% |
| Mechanical Manual Wheelchair | 10,279 | 0 | 0% |
| Transport 20 In X 16 In 9153637574 | 1,973 | 0 | 0.1% |
| Daily Activity Assist Devices | 3,385 | 0 | 0% |
| Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back | 608 | 0 | 0% |
| Invacare | 200 | 0 | 17% |
| Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 9153649403 | 285 | 0 | 0% |
| Powered Wheelchair | 18,464 | 0 | 0.1% |
| Donjoy | 164 | 3 | 0% |
| Invacare Power Wheelchair | 248 | 0 | 5.2% |
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 Drive Medical reports
How many FDA reports name Drive Medical?
290 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?
injury (82.8%), death (10%) and malfunction (5.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (8.3%), collapse (8.3%), detachment of device component (6.9%), insufficient device problem information (5.9%) and detachment of device or device component (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (84.8%), manufacturer reports (10%) and voluntary reports (4.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Drive Medical 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.