FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER ET
MDR report key: 1702077
·
Received May 27, 2010
Report
- Report Number
- 2914019-2010-00026
- Event Type
- Injury
- Date Received
- May 27, 2010
- Date of Event
- April 29, 2010
- Report Date
- May 27, 2010
- Manufacturer
- RH USA, INC
- Product Code
- GEX
- PMA / PMN Number
- K003614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REASONABLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY, HOWEVER, NONE WAS PROVIDED. A REVIEW OF SERVICE RECORDS FOR THE USER FACILITY CONCLUDED THAT NO SERVICE HAD BEEN PERFORMED BY LUMENIS SINCE 04/05/2005. A REVIEW OF THE REPORTED EVENT DETAILS CONCLUDED THAT INSUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE A ROOT CAUSE. SHOULD ADDITIONAL INFORMATION BE REPORTED A FOLLOW UP MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT SUSTAINED SCARRING 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 |