FDA Adverse Event
Injury
Summary report: N
CARDINAL
MDR report key: 2979882
·
Received February 22, 2013
Report
- Report Number
- 1836161-2013-00035
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- October 20, 2010
- Report Date
- February 22, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- FZZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.
Description of Event or Problem · 1
DURING PREPARATION FOR SURGERY DR. (B)(6) WENT TO MARK THE CORNEA BUT AT THE SAME TIME, THE MARKER BLED ALL OVER THE PT'S EYE. HE IRRIGATED THE EYE THOROUGHLY AND THEN PROCEEDED WITH THE SURGERY. THE PT CAME OUT OF SURGERY VERY WELL, BUT THEY NOW HAVE A BLUE CONJUNCTIVA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78500 | CARDINAL | SURGICAL SKIN MARKER | FZZ | ASPEN SURGICAL PRODUCTS, INC. | 2010-03-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |