FDA Adverse Event
Malfunction
Summary report: N
STELLARIS POSTERIOR VITRECTOMY PACK
MDR report key: 3853443
·
Received April 4, 2014
Report
- Report Number
- 1920664-2014-00404
- Event Type
- Malfunction
- Date Received
- April 4, 2014
- Date of Event
- December 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K101325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN REQUESTED FOR EVALUATION. HOWEVER, IT HAS NOT YET BEEN RECEIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2013-00402, 00403 AND 00405.
Description of Event or Problem · 1
REPORT RECEIVED FROM THE (B)(6) WHICH STATES: "THE SURGEON HAD COMMENCED CUTTING THE VITREOUS AND SUDDENLY THE CUTTER STOPPED BUT STARTED AGAIN A FEW SECONDS LATER ONLY TO STOP AGAIN." NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205101 | STELLARIS POSTERIOR VITRECTOMY PACK | HQC | BAUSCH & LOMB, INC. | V0624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |