FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2942709
·
Received February 4, 2013
Report
- Report Number
- 1525712-2013-00805
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Report Date
- February 4, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. REPLACEMENT PARTS WERE SENT FOR DEALER TO REPAIR. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
PROVIDER STATES CROSSBAR GOT STUCK ON RIGHT SIDE STROLLER HANDLE. BOTH CRACKED AND STUCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46015 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET | 1129475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |