FDA Adverse Event
Other
Summary report: N
LIGHTSHEER DUET
MDR report key: 1574965
·
Received January 8, 2010
Report
- Report Number
- 2914019-2010-00002
- Event Type
- Other
- Date Received
- January 8, 2010
- Date of Event
- December 3, 2009
- Report Date
- January 8, 2010
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K053628
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THAT THE TREATMENT PARAMETERS USED BY THE USER FACILITY WERE WITHIN THOSE IN THE SUBJECT DEVICE TRAINING MATERIALS AND THE COMMON PRACTICE FOR THE SUBJECT INDICATION. NO RELATED DEVICE MALFUNCTION WAS REPORTED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL RELEVANT INFORMATION; HOWEVER, NON WAS PROVIDED BY THE USER FACILITY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT SUSTAINED BLISTERS AND SCABBING TO THE BACK OF THE THIGH AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED THAT BIAFINE WAS PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHTSHEER DUET | OTHER: DIODE | GEX | RH USA, INC. | LIGHTSHEER DUET | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |