FDA Adverse Event
Injury
Summary report: N
STORZ CASTROVIEJO SPATULA
MDR report key: 3709233
·
Received March 19, 2014
Report
- Report Number
- 1920664-2014-00041
- Event Type
- Injury
- Date Received
- March 19, 2014
- Date of Event
- February 18, 2014
- Report Date
- February 18, 2014
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HNR
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REPORT 4 OF 4. SEE 1920664-2014-00027, 1920664-2014-00039, 1920664-2014-00040.
Description of Event or Problem · 1
THE USER FACILITY IN THAILAND REPORTED A SCLERAL TEAR AS THE INSTRUMENT WAS IN CONTACT WITH THE PT'S EYE. SUTURE WAS REQUIRED TO CLOSE THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165210 | STORZ CASTROVIEJO SPATULA | HNR | BAUSCH & LOMB, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |