FDA Adverse Event
Malfunction
Summary report: N
SOLARA 3G LTD 20W 12 COM 9153653248
MDR report key: 5270221
·
Received December 7, 2015
Report
- Report Number
- 1525712-2015-05575
- Event Type
- Malfunction
- Date Received
- December 7, 2015
- Report Date
- November 24, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
LEFT SCREWS THAT SECURE THE BACK BOW AND THE SEAT FRAME IS BROKEN. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
LEFT SCREWS THAT SECURE THE BACK BOW AND THE SEAT FRAME IS BROKEN. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801943 | SOLARA 3G LTD 20W 12 COM 9153653248 | WHEELCHAIR, MECHANICAL | IOR | INVACARE TAYLOR STREET | SOLARA 3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |