FDA Adverse Event
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2981852
·
Received February 27, 2013
Report
- Report Number
- 1531186-2013-00786
- Date Received
- February 27, 2013
- Report Date
- January 31, 2013
- Manufacturer
- GOODBABY
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT ONE OF THE TREX28R MECHANICAL WHEELCHAIR SPOKE WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83215 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | GOODBABY | TREX28R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |