FDA Adverse Event
Injury
Summary report: N
LUMENIS ONE
MDR report key: 1221990
·
Received November 6, 2008
Report
- Report Number
- 2914019-2008-00059
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- October 6, 2008
- Report Date
- November 6, 2008
- Manufacturer
- LUMENIS, INC.
- Product Code
- GEX
- PMA / PMN Number
- K060448
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY LUMENIS FIELD SERVICE INVESTIGATION FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. SUBJECT DEVICE WAS REQUESTED TO BE RETURNED TO THE LUMENIS MFG SITE FOR FULL FUNCTIONAL ANALYSIS. SHOULD THE DEVICE BE RETURNED, A FOLLOW UP MDR WILL BE FILLED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT SUSTAINED A SMALL SECOND DEGREE BURN AS A RESULT OF A HAIR REMOVAL TREATMENT TO THE BACK. PATIENT WAS REPORTED TO HAVE FULLY RECOVERED WITHOUT ANY SCARRING. NO MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMENIS ONE | LASER POWERED SURGICAL INSTRUMENT | GEX | LUMENIS, INC. | GAL140000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |