FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2930602
·
Received January 28, 2013
Report
- Report Number
- 1531186-2013-00311
- Date Received
- January 28, 2013
- Report Date
- January 25, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THE CROSS BAR THAT HOLDS UP THE SEAT IS BROKEN. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37625 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |