FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2990677
·
Received March 5, 2013
Report
- Report Number
- 1531186-2013-00889
- Date Received
- March 5, 2013
- Report Date
- February 11, 2013
- Manufacturer
- KENSTONE METAL
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATING THE BRAKE SHOES JUST FELL OFF AND CANNOT BE REPLACED. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93273 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENSTONE METAL | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |