FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER (ALL MODELS)
MDR report key: 2023366
·
Received March 16, 2011
Report
- Report Number
- 1720381-2011-00007
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- September 3, 2010
- Report Date
- March 17, 2011
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K003614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE REPORTED EVENT, TREATMENT SETTINGS, AND PHOTOGRAPHS OF THE PT BY A LUMENIS HEALTH PROFESSIONAL CONCLUDED THE PROBABLE CAUSE OF THE EVENT TO BE EXCESSIVE TREATMENT SETTINGS EMPLOYED FOR THE PT'S SKIN TYPE IN CONTRADICTION TO COMMON MEDICAL PRACTICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT SUSTAINED A SCAR TO THE UPPER LIP AS A RESULT OF HAIR REMOVAL TREATMENT WITH THE LUMENIS LIGHTSHEER LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHTSHEER (ALL MODELS) | SOLID STATE AESTHETIC LASER DELIVERY DEVICE: DIODE | GEX | RH USA, INC. | ET | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other |