FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3883969
·
Received June 19, 2014
Report
- Report Number
- 1056571-2014-00023
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- May 20, 2014
- Manufacturer
- INVACARE TOP END
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THE MOUNTING SCREWS ON A (B)(4) WHEELCHAIR FOR THE LEFT SIDE CAMBER TUBE CLAMP HAVE SHEARED OFF AND THE ANTI TIPPER ON THE LEFT SIDE CANNOT BE MOUNTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361296 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TOP END | CT7A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |