FDA Adverse Event
Other
Summary report: N
CV EVOLUTIONS SAPHLITE
MDR report key: 1230259
·
Received November 7, 2008
Report
- Report Number
- 1044475-2008-00036
- Event Type
- Other
- Date Received
- November 7, 2008
- Report Date
- October 15, 2008
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KDQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN RETURNED FOR INVESTIGATION. INVESTIGATION ONGOING AND IS NOT COMPLETE AT TIME OF THIS REPORT. A FOLLOW UP REPORT WILL FOLLOW WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE COMPLAINT DESCRIPTION WAS REPORTED AS: DURING A PROCEDURE, THE DEVICE WAS USED WHILE TAKING A VEIN GRAFT. IT WAS REPORTED THAT PATIENT WAS BURNED AT THREE INCISION SITES. SURGERY WAS NOT DELAYED, BUT PATIENT WAS TREATED WITH A BURN OINTMENT TO THE AFFECTED AREAS AND A STERILE DRESSING WAS APPLIED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CV EVOLUTIONS SAPHLITE | SAPHLITE | KDQ | TELEFLEX MEDICAL | NA | 622805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |