FDA Adverse Event
Injury
Summary report: N
DMI - 3-WHEEL ALUMINUM ROLLATOR W/ BASKET
MDR report key: 25319698
·
Received May 28, 2026
Report
- Report Number
- 1000143485-2026-29078
- Event Type
- Injury
- Date Received
- May 28, 2026
- Date of Event
- March 1, 2026
- Report Date
- May 28, 2026
- Manufacturer
- AHT ENTERPRISE CORPORATION
- Product Code
- ITJ
- UDI-DI
- 00041298003571
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
USER INDICATED THE WELD FOR THE WHEEL ASSEMBLY BROKE AND THE WHEEL BROKE OFF CAUSING THEM TO FALL TO THE GROUND. THE UNIT FELL ON THEIR LEG AND SHE WENT TO THE DOCTOR AND X-RAYS WERE TAKEN, AMBULANCE WAS NOT REQUIRED. DOCTOR INDICATED THERE WAS A FRACTURE AND RELEASED USER WITH AN ACE BANDAGE AND A SURGICAL SHOE, NO BRACE OR CAST APPLIED.
Description of Event or Problem · 0
USER REPORTED - THE FRONT WHEEL FELL OFF, I HAD THE HANDLEBARS IN MY HAND AND THE WALKER WENT DOWN. MY HANDS WENT DOWN WITH IT AND MY FOOT GOT FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576370 | DMI - 3-WHEEL ALUMINUM ROLLATOR W/ BASKET | 3-WHEEL ALUMINUM ROLLATOR W/ BASKET | ITJ | AHT ENTERPRISE CORPORATION | 501-2014-2100 | 5391210422 | 00041298003571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Other |