FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3884398
·
Received June 19, 2014
Report
- Report Number
- 1531186-2014-02176
- Date Received
- June 19, 2014
- Report Date
- May 20, 2014
- Manufacturer
- CONSMA
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE END USER'S CHILD STATES THE WHEEL ON AN UNKNOWN ROLLATOR BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362012 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | CONSMA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |