FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2890379
·
Received December 29, 2012
Report
- Report Number
- 1525712-2012-03370
- Event Type
- Malfunction
- Date Received
- December 29, 2012
- Report Date
- December 29, 2012
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
A REPORT HAS BEEN RECEIVED WHERE THE BOLTS SHEARED OFF. STATES THE PARTS TO THE RECLINE BACK ARE POOR QUALITY. DISSATISFIED WITH THE QUALITY OF THE RECLINING BACK. IT WAS REPORTED THAT THE CHILD HAS INCREDIBLE TONE. PLEASE NOTE ANY FURTHER INFORMATION RECEIVED WILL BE PROVIDED IN A FOLLOW UP REPORT. THERE IS NO INFORMATION OF INJURY OR ILL EFFECT TO THE END USER OF THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |