FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3910870
·
Received July 2, 2014
Report
- Report Number
- 1531186-2014-02352
- Date Received
- July 2, 2014
- Date of Event
- May 31, 2014
- Report Date
- June 2, 2014
- Manufacturer
- DANYANG MAXTHAI MEDICAL EQUIPMENT
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
END USER LOST HIS BALANCE AND HE FELL; WHEN HE FELL THE ROLLATOR BENT - ALLEGES THAT THE FRAME IS ALREADY BENT IN THE REAR AND IT SHOULDN'T BE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388599 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | DANYANG MAXTHAI MEDICAL EQUIPMENT | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |