FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3844017
·
Received June 2, 2014
Report
- Report Number
- 1531186-2014-02053
- Date Received
- June 2, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 16, 2014
- Manufacturer
- CONSMA
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER ALLEGES THAT THE ROLLATOR LEFT BRAKE HANDLE BROKE WHERE THE SCREWS ARE ON THE SIDE OF THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321630 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | CONSMA | 65851B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |