FDA Adverse Event
Summary report: N
SURGITRON
MDR report key: 865419
·
Received June 13, 2007
Report
- Report Number
- 2428235-2007-00001
- Date Received
- June 13, 2007
- Date of Event
- January 28, 2005
- Report Date
- June 1, 2007
- Manufacturer
- ELLMAN INT'L INC.
- Product Code
- BWA
- PMA / PMN Number
- K972072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSICIAN ADMITTED TO USING WRONG SETTING FOR PROCEDURE. HE USED SETTING OF 2.5 ON CUT/COAG CURRENT RATHER THAN THE RECOMMENDED SETTING OF BETWEEN 1 - 2, IN PARTIALLY RECTIFIED CURRENT. PHYSICIAN WAS ASKED TO SUBMIT FULL OP REPORT, WHICH HAS NOT YET BEEN REC'D.
Description of Event or Problem · 1
AS A RESULT OF TURBINATE VOLUME REDUCTION PROCEDURE, PT SUFFERED BONE LOSS AND LOSS OF SENSE OF SMELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITRON | BWA | ELLMAN INT'L INC. | FFPF EMC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Disability |