FDA Adverse Event
Other
Summary report: N
XEO 1064NM ND:YAG LASER
MDR report key: 2130685
·
Received June 2, 2011
Report
- Report Number
- 2954354-2011-00009
- Event Type
- Other
- Date Received
- June 2, 2011
- Date of Event
- April 7, 2011
- Report Date
- May 27, 2011
- Manufacturer
- CUTERA BRISBANE
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE TREATMENT WAS (B)(6) 2011 BUT THE ADVERSE EVENT WAS NOT REPORTED TO CUTERA UNTIL (B)(4) 2011. IT IS UNKNOWN WHAT THE WOUND CARE WAS FOR THE REPORTED BURNS. IT WAS REPORTED THAT THE BURNS "HEALED WITH DIVOT SCARS". THE LASER WAS EVALUATED AND FOUND TO BE OPERATING WITHIN SPECIFICATION.
Description of Event or Problem · 1
PATIENT TREATED FOR "REDNESS/VASCULAR" ISSUES ON THE FACE. PATIENT DEVELOPED BLISTERS THAT RESULTED IN "DIVOT SCARS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XEO 1064NM ND:YAG LASER | XEO | GEX | CUTERA BRISBANE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | TO THE VASCULAR TREATMENT| ABLATIVE ERBIUM LASER APPROXIMATELY 2 WEEKS PRIOR |