FDA Adverse Event
Other
Summary report: N
9613347-2009-00006
MDR report key: 1344846
·
Received March 11, 2009
Report
- Report Number
- 9613347-2009-00006
- Event Type
- Other
- Date Received
- March 11, 2009
- Product Code
- LQR
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
HEMATOMA IS A KNOWN SIDE EFFECT OF LITHOTRIPSY TREATMENT AND IS ADDRESSED IN OUR LABELING. UNIT WAS INSTALLED IN 2009; COMPLETE INSTALLATION TESTING WAS DONE AT THE TIME; ADDITIONALLY CSA TESTING WAS DONE FIVE DAYS LATER; UNIT PASSED ALL TESTS. NO MALFUNCTION WAS NOTED AT THAT TIME OF THE PROCEDURE. UNIT HAS BEEN IN CONTINUOUS SERVICE SINCE THE EVENT. THE HOSP HAS TREATED APPROX 120-130 PTS WITH NO PROBLEMS REPORTED. THERE IS NO PLAN TO SCHEDULE EVAL OF UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LQR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |