FDA Adverse Event
Other
Summary report: N
CERALAS
MDR report key: 2212505
·
Received March 20, 2007
Report
- Report Number
- 1222625-2007-00002
- Event Type
- Other
- Date Received
- March 20, 2007
- Manufacturer
- BIOLITEC
- Product Code
- GEX
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY HAS BECOME AWARE THAT THERE MAY HAVE BEEN A PROBLEM WITH OUR DEVICE. THE COMPANY HAS REPEATEDLY MADE EFFORTS TO ASCERTAIN THE INFORMATION BUT TO NO AVAIL. THE COMPANY BELIEVES IT PRUDENT TO SUBMIT THIS REPORT.
Description of Event or Problem · 1
UNKNOWN PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERALAS | FIBER OPTIC DELIVERY SYSTEM | GEX | BIOLITEC | SF2100H | A07-0105A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |