FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER ET
MDR report key: 1612453
·
Received February 19, 2010
Report
- Report Number
- 2914019-2010-00008
- Event Type
- Injury
- Date Received
- February 19, 2010
- Date of Event
- January 3, 2008
- Report Date
- February 19, 2010
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K003614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO RELATED SUBJECT DEVICE MALFUNCTION WAS REPORTED; THEREFORE NO INVESTIGATION OF THE DEVICE WAS PERFORMED. A REVIEW OF THE SERVICE RECORDS FOR THE SUBJECT DEVICE CONCLUDED THAT NO PREVENTATIVE MAINTENANCE HAD BEEN PERFORMED SINCE (B) (6) 2005 IN CONTRAINDICATION TO DEVICE LABELING REQUIREMENTS FOR ANNUAL SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT SUSTAINED FIRST AND SECOND DEGREE BURNS AND BLISTERS ON THE UNDERARMS AND BIKINI AREA AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER ET LASER. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTION WAS ADMINISTERED TO THE PATIENT AT ANOTHER MEDICAL FACILITY.
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 | 44 YR |