FDA Adverse Event
Other
Summary report: N
IPL QUANTUM
MDR report key: 1200283
·
Received October 2, 2008
Report
- Report Number
- 2914019-2008-00050
- Event Type
- Other
- Date Received
- October 2, 2008
- Date of Event
- July 28, 2008
- Report Date
- September 26, 2008
- Manufacturer
- LUMENIS, LTD
- Product Code
- GEX
- PMA / PMN Number
- K020839
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE SYSTEM BY FACILITY (DISTRIBUTOR), VERIFIED THE INTERNAL COMPONENTS, VOLTAGES AND HEADS WERE WITHIN OPERATIONAL SPECIFICATIONS. UNIT PASSED ALL TESTS. NO ROOT CAUSE TO REPORTED EVENT COULD BE LINKED TO DEVICE. REASONABLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL PATIENT OUTCOME AND TREATMENT INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO LUMENIS IN 2008, A PATIENT SUSTAINED "BRUISING" ON THE RIGHT SIDE OF HER FACE AS A RESULT OF A PHOTOREJUVENTATION TREATMENT WITH AN IPL QUANTUM. THIS WAS THE PATIENTS' SECOND TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IPL QUANTUM | IPL QUANTUM | GEX | LUMENIS, LTD | GA3698000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |