FDA Adverse Event
Malfunction
Summary report: N
SOLARA 3G LTD 20W 24 COM 9153653250
MDR report key: 4543142
·
Received February 25, 2015
Report
- Report Number
- 9616091-2015-00550
- Event Type
- Malfunction
- Date Received
- February 25, 2015
- Report Date
- February 18, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER IS STATING THAT PART # 1087472 IN PART # 1171136 KEEPS BACKING IT SELF OUT, CAUSING THE UPPER RECLINING BACK LINK TO GET STRIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132184 | SOLARA 3G LTD 20W 24 COM 9153653250 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |