FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 953876
·
Received November 20, 2007
Report
- Report Number
- 2090040-2007-00013
- Event Type
- Malfunction
- Date Received
- November 20, 2007
- Date of Event
- September 27, 2007
- Report Date
- November 20, 2007
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- NKX
- PMA / PMN Number
- K050518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USED DEVICE HAS BEEN RETURNED, HOWEVER, A DEVICE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A F/U MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHACO TIP BROKE OFF IN THE PT'S EYE. IT WAS REMOVED BY THE PHYSICIAN. NO INJURY TO THE PT OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | NKX | ASCENT HEALTHCARE SOLUTIONS | 8065740839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |