FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 6210635
·
Received April 26, 2013
Report
- Report Number
- 1000282279-2013-00006
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Manufacturer
- FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FROM IMPORTER REPORT: 01/04/2013 - RBS - THE DEALER REPORTED THAT THE 66500 ROLLATOR BRAKE CABLE WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183561 | MECHANICAL WALKER, ROLLATOR | MECHANICAL WALKER | ITJ | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. | 66500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |