FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2781784
·
Received October 11, 2012
Report
- Report Number
- 1531186-2012-01155
- Date Received
- October 11, 2012
- Report Date
- October 10, 2012
- Manufacturer
- DANYANG MAXTHAI MEDICAL EQUIPMENT
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(6) 2012 - THE DEALER REPORTED THAT DURING USE OF THE 65650 ROLLATOR AND WHEN TRYING TO APPLY BRAKES, THE RIGHT BRAKE HANDLE BROKE AND SNAPPED OFF ENTIRELY. THERE WAS NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | DANYANG MAXTHAI MEDICAL EQUIPMENT | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 | Other |