Device brand name · Walker
Guardian: medical device reports filed with FDA
557 reports name it, 1996–2026. Manufacturer given most often on reports: Medline Industries. Product code ITJ.
- 557
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 350
- reports, 12 months to August 2026
- 0 in the 12 months before
- 72.2%
- classified as malfunction
- 54.4% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
557 medical device reports received by FDA name the brand "Guardian" (walker); the manufacturer given most often on reports is Medline Industries; received from August 1996 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
350 reports arrived in the 12 months to August 2026, with 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 (72.2%), other (19%) and injury (8.1%); 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 fracture (16%), material twisted/bent (16%) and break (6.8%). The patient problems coded most often are fall, bone fracture(s) and hospitalization required. 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 |
|---|---|---|---|
| Fracturea broken bone | 89 | 16% | 12.1% |
| Material twisted/bent | 89 | 16% | 6.7% |
| Breakthe device broke | 38 | 6.8% | 22.6% |
| Detachment of device or device componentpart of the device came off | 28 | 5% | 2.2% |
| Unstable | 25 | 4.5% | 13.3% |
| Component(s), broken | 24 | 4.3% | 0.5% |
| Activation problem | 22 | 3.9% | 4.2% |
| Mechanical problema mechanical problem | 22 | 3.9% | 2.9% |
| Loose or intermittent connection | 18 | 3.2% | 3.5% |
| Crackthe device cracked | 16 | 2.9% | 4.2% |
| Mechanical jam | 15 | 2.7% | 1.4% |
| Component missing | 13 | 2.3% | 1% |
| Computer operating system problem | 11 | 2% | 0% |
| Material separation | 9 | 1.6% | 0.8% |
| Loss of or failure to bond | 7 | 1.3% | 0.1% |
| Failure to back-up | 6 | 1.1% | 0% |
| Unintended movement | 5 | 0.9% | 1.1% |
| Bent | 4 | 0.7% | 2.9% |
| Defective devicethe device was defective | 4 | 0.7% | 0.2% |
| Detachment of device component | 4 | 0.7% | 4.2% |
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) | Reports | Share |
|---|---|---|
| Falla fall | 30 | 5.4% |
| Bone fracture(s) | 6 | 1.1% |
| Hospitalization required | 5 | 0.9% |
| Hip fracturea broken hip | 4 | 0.7% |
| Therapy/non-surgical treatment, additional | 4 | 0.7% |
| Bruise/contusion | 3 | 0.5% |
| Cut(s) | 3 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 0.5% |
| Injurya physical injury | 3 | 0.5% |
| Abrasion | 2 | 0.4% |
| Painpain, site not specified | 2 | 0.4% |
| Surgical procedure | 2 | 0.4% |
| Bleeding | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Dural tear | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Guardian | Product code ITJ | All MAUDE reports |
|---|---|---|---|
| Reports | 557 | 15,177 | 26,136,888 |
| Share of that pool | — | 3.7% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 8.1% | 10.5% | 36.2% |
| Classified as malfunction | 72.2% | 54.4% | 62.3% |
| Filed by the manufacturer | 91% | 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% |
| Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547 | 169 | 0 | 0% |
| Drive Medical | 290 | 0 | 10% |
| 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 Guardian reports
How many FDA reports name Guardian?
557 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 350 in the latest 12 months.
What kinds of events are reported?
malfunction (72.2%), other (19%) and injury (8.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (16%), material twisted/bent (16%), break (6.8%), detachment of device or device component (5%) and unstable (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (91%), distributor reports (5.4%) and voluntary reports (1.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Guardian 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.