FDA Adverse Event
Injury
Summary report: N
LIGHTSHEER ET
MDR report key: 1586198
·
Received January 21, 2010
Report
- Report Number
- 2914019-2010-00004
- Event Type
- Injury
- Date Received
- January 21, 2010
- Date of Event
- December 26, 2009
- Report Date
- January 21, 2010
- Manufacturer
- RH USA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K003614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. REASONABLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY, HOWEVER, NONE WAS PROVIDED. 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 SECOND DEGREE BURNS ON THE UNDERARMS AND LEGS 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 |