FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3013905
·
Received March 20, 2013
Report
- Report Number
- 1525712-2013-02138
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- February 22, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES PIN THAT HOLDS LEVER ON CAME OFF AND SPRING IS MISSING. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115560 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | ITJ | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |