FDA Adverse Event
Other
Summary report: N
FORTEC FIBER
MDR report key: 1031774
·
Received April 18, 2008
Report
- Report Number
- 1222625-2008-00001
- Event Type
- Other
- Date Received
- April 18, 2008
- Date of Event
- April 3, 2008
- Manufacturer
- BIOLITEC
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FIBER TIP OF LASER DELIVERY SYSTEM BROKE OFF. NO INJURY TO THE PATIENT. MAY HAVE BEEN DUE TO OPERATOR TECHNIQUE.
Description of Event or Problem · 1
THE COMPANY HAS BECOME AWARE OF THE FOLLOWING EVENT: 2008, FIBER TIP OF LASER MALFUNCTIONED. NO INJURY TO THE PATIENT. PRODUCT DISTRIBUTED BY COMPANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORTEC FIBER | FIBEROPTIC LASER DELIVERY FIBER | GEX | BIOLITEC | C07-0433A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |