FDA Adverse Event
Injury
Summary report: N
FRAXEL LASER SYSTEM
MDR report key: 974907
·
Received March 7, 2006
Report
- Report Number
- 2950711-2006-00003
- Event Type
- Injury
- Date Received
- March 7, 2006
- Date of Event
- November 2, 2005
- Report Date
- February 17, 2006
- Manufacturer
- RELIANT TECHNOLOGY
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FACTORY TEST REPORTS INDICATED THAT M0488 PERFORMED AS EXPECTED. CALIBRATION AND POWER OUTPUTS WERE FOUND TO MEET PRODUCT SPECIFICATIONS. REVIEW OF THE MANUFACTURING RECORDS AND DHR FOR THE SYSTEM NOTED NO NON-CONFORMANCE RELATED TO THE EVENT. SEE SCANNED PAGE.
Description of Event or Problem · 1
IN 2005, PATIENT DEVELOPED A BLISTERING RESPONSE IN THE CHEEK AND MANDIBLE REGIONS FOLLOWING HER SECOND TREATMENT WITH THE FRAXEL SR LASER SYSTEM. THE SECOND TREATMENT WITH THE FRAXEL SR LASER SYSTEM WAS ADMINISTERED AT A SETTING OF 2000 MTZ/CM2 AND 12MJ. THE PHYSICIAN (DR. BARTON) REPORTED ON 03/06/06 (DATE OF REPORTABILITY) THAT THE PATIENT DEVELOPED A SCAR ALONG THE RIGHT CHEEK/JAW LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRAXEL LASER SYSTEM | SURGICAL LASER | GEX | RELIANT TECHNOLOGY | 00-01680-000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other | SILVADENE| TEMOVATE BID |