FDA Adverse Event
Injury
Summary report: N
SURGITRON
MDR report key: 3750790
·
Received April 13, 2006
Report
- Report Number
- 2428235-2006-00001
- Event Type
- Injury
- Date Received
- April 13, 2006
- Date of Event
- January 1, 2006
- Report Date
- April 13, 2006
- Manufacturer
- ELLMAN INTERNATIONAL, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED OF REPORTER.
Description of Event or Problem · 1
PHYSICIAN CUT THROUGH PT'S EYELID DURING PROCEDURE WHICH TOOK PLACE IN (B)(6) 2006. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITRON | ESU HANDPIECE | GEI | ELLMAN INTERNATIONAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |