FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER DUET
MDR report key: 1623562
·
Received March 4, 2010
Report
- Report Number
- 2914019-2010-00010
- Event Type
- Injury
- Date Received
- March 4, 2010
- Date of Event
- January 23, 2010
- Report Date
- March 4, 2010
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K053628
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE REPORTED, TREATMENT SETTINGS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE TO BE FAILURE TO LOWER ENERGY LEVELS FOR THE TREATMENT OF TANNED SKIN IN CONTRAINDICATION TO DEVICE LABELING.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT SUSTAINED A SECOND DEGREE BURN ON THE LEG AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER DUET LASER RESULTING IN A SCAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHTSHEER DUET | DIODE | GEX | RH USA, INC. | LIGHTSHEER DUET | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |