FDA Adverse Event
Other
Summary report: N
LUMENIS ONE
MDR report key: 1200343
·
Received October 9, 2008
Report
- Report Number
- 2914019-2008-00055
- Event Type
- Other
- Date Received
- October 9, 2008
- Date of Event
- September 11, 2008
- Report Date
- October 9, 2008
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K060448
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS EVALUATED BY LUMENIS SERVICE AND FOUND TO BE OUT OF CALIBRATION. USER FACILITY HAD NOT CONDUCTED MANDATORY PERIODIC DEVICE CALIBRATION IN CONTRADICTION TO DEVICE LABELING AND PRODUCT TRAINING. REASONABLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL PATIENT OUTCOME INFORMATION, NONE WAS PROVIDED BY THE USER FACILITY. SHOULD ADDITIONAL INFORMATION BE PROVIDED A FOLLOW UP MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT BLISTERED AS A RESULT OF IPL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMENIS ONE | LUMENIS ONE | GEX | LUMENIS LTD | GAL110000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |