FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3243245
·
Received July 23, 2013
Report
- Report Number
- 1531186-2013-03331
- Date Received
- July 23, 2013
- Report Date
- July 3, 2013
- Manufacturer
- CONSMA
- Product Code
- ITJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROVIDER STATES END USER PURCHASED UNIT IN (B)(6) 2013 AND SEAT BROKE ON UNIT ALREADY. END-USER HAS SEEN DOCTOR OR HOSPITAL DUE TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343161 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | CONSMA | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |