FDA Adverse Event
Injury
Summary report: N
ELLMAN SURGITRON FFPF OPHTHALMOLOGY
MDR report key: 885909
·
Received July 2, 2007
Report
- Report Number
- 2428235-2007-00002
- Event Type
- Injury
- Date Received
- July 2, 2007
- Date of Event
- February 16, 2007
- Report Date
- June 25, 2007
- Manufacturer
- ELLMAN INTERNATIONAL, INC.
- Product Code
- BWA
- PMA / PMN Number
- K955158
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS SERIAL NUMBER DATES TO CIRCA 1992. ELLMAN INTERNATIONAL HAS NO RECORD OF EVER SERVICING THIS DEVICE. THE USER FACILITY HAS BEEN ASKED TO SUBMIT THE DEVICE TO ELLMAN INTERNATIONAL, ALONG WITH OPERATIONS REPORT FOR OUR EVAL.
Description of Event or Problem · 1
DURING ROUTINE UPPER AND LOWER LID BLEPHAROPLASTY, CUSTOMER CLAIMS ELLMAN SURGITRON MALFUNCTIONED CREATING A FULL THICKNESS CORNEAL LACERATION. THE CORNEA WAS SEWED UP AFTER THE EVENT IN THE PHYSICIAN'S OFFICE AND REFERRED TO CORNEAL SPECIALIST FOR CONTINUING CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELLMAN SURGITRON FFPF OPHTHALMOLOGY | BWA | BWA | ELLMAN INTERNATIONAL, INC. | OP110 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |