FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3883792
·
Received June 19, 2014
Report
- Report Number
- 9616091-2014-01052
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- May 20, 2014
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER STATED THE RIGHT BRAKE FELL OFF THE SIDE OF CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361648 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | SD2228F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 | Other |