FDA Adverse Event
Injury
Summary report: N
SURGITRON FFPF EMC
MDR report key: 1487323
·
Received September 29, 2009
Report
- Report Number
- 2428235-2009-00003
- Event Type
- Injury
- Date Received
- September 29, 2009
- Date of Event
- August 1, 2009
- Report Date
- August 17, 2009
- Manufacturer
- ELLMAN INTERNATIONAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K972072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE HAVE REQUESTED AND ARE AWAITING ADDITIONAL INFO CONCERNING THE DETAILS OF THE PROCEDURE AND PT'S CONDITION FROM OUR DISTRIBUTOR IN A FOREIGN COUNTRY. WE HAVE ONLY BEEN TOLD THAT THE PHYSICIAN ROUTINELY USES THIS EQUIPMENT FOR TURBINATE REDUCTION AND TONSILLECTOMIES. WE HAVE ALSO REQUESTED RETURN OF THE UNIT FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TONSILLECTOMY USING THE SURGITRON FFPF EMC GENERATOR THE PT SUFFERED SEVERE NECROSIS AND BLEEDING. WE HAVE BEEN TOLD THE PT REQUIRED INTERVENTION, BUT WE HAVE YET TO RECEIVE THE DETAILS OF THE INCIDENT OR THE PRESENT CONDITION OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITRON FFPF EMC | GEI | ELLMAN INTERNATIONAL, INC. | EMC220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |