FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3151010
·
Received June 6, 2013
Report
- Report Number
- 1531186-2013-02478
- Date Received
- June 6, 2013
- Date of Event
- May 5, 2013
- Report Date
- May 10, 2013
- Manufacturer
- DANYANG MAXTHAI MEDICAL EQUIPMENT
- Product Code
- IOR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CONSUMER REPORTS BRAKES DID NOT HOLD, ROLLATOR SPUN HIM OUT AND HE FELL FORWARD AND CUT HEAD. NEXT DAY IT FLIPPED HIM BACKWARDS AND HURT BACK AND RIBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250095 | MECHANICAL WALKER, ROLLATOR | 890.3825 | IOR | DANYANG MAXTHAI MEDICAL EQUIPMENT | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 | Other |