FDA Adverse Event
Malfunction
Summary report: N
STELLARIS 25G VITRECTOMY PACK W AFI&WF
MDR report key: 3963574
·
Received May 30, 2014
Report
- Report Number
- 1920664-2014-00083
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 15, 2014
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K101325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 2, SEE 1920664-2014-00084.
Description of Event or Problem · 1
THE USER FACILITY IN (B)(6) REPORTED THAT THE CUTTER DID NOT CUT. A REPLACEMENT CUTTER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319799 | STELLARIS 25G VITRECTOMY PACK W AFI&WF | HQC | BAUSCH & LOMB, INC. | U9650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |