FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER ET
MDR report key: 1604445
·
Received February 9, 2010
Report
- Report Number
- 2914019-2010-00005
- Event Type
- Injury
- Date Received
- February 9, 2010
- Date of Event
- January 11, 2010
- Report Date
- February 9, 2010
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K003614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENT TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE USER FACILITY IN CONTRADICTION TO PRODUCT LABELING.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO PTS SUSTAINED BURNS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER ET LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHTSHEER ET | DIODE | GEX | RH USA, INC. | LIGHTSHEER ET | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |