FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4090168
·
Received September 15, 2014
Report
- Report Number
- 1531186-2014-04118
- Date Received
- September 15, 2014
- Date of Event
- August 9, 2014
- Report Date
- August 27, 2014
- Manufacturer
- CONSMA
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
END USER REPORTED THAT WHEN SHE WAS NAVIGATING HER 65350GR ROLLATOR OUT OF HER DOOR, SHE FELL DOWN THE STEPS. SHE WAS BRUISED AND SORE, MEDICAL ATTENTION ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568546 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | CONSMA | 65350GR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 MO | Other |