FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3061202
·
Received April 16, 2013
Report
- Report Number
- 1531186-2013-01579
- Date Received
- April 16, 2013
- Report Date
- March 19, 2013
- Manufacturer
- CONSMA
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER (B)(6) WITH DEALER, REAR BEARINGS CAME OUT OF ONE CASTER AND ARE READY TO COME OUT OF THE OTHER. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162458 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | CONSMA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |