FDA Adverse Event
Malfunction
Summary report: N
STELLARIS 20GA POSTERIOR PACK W AFI & FF
MDR report key: 2896740
·
Received December 28, 2012
Report
- Report Number
- 1920664-2012-00263
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 30, 2012
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K101325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.
Description of Event or Problem · 1
REPORT RECEIVED FROM FRANCE STATES: "DISCONNECTION OF TUBING FROM THE VITRECTOMY CUTTER, PACK EXCHANGED, NO PT IMPACT. ISSUE: SURGERY TIME INCREASED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS 20GA POSTERIOR PACK W AFI & FF | HQC | BAUSCH & LOMB, INC. | BL5420W | U7333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |