FDA Adverse Event
Other
Summary report: N
XEO 1064NM ND: YAG LASER
MDR report key: 2467765
·
Received February 16, 2012
Report
- Report Number
- 2954354-2012-00005
- Event Type
- Other
- Date Received
- February 16, 2012
- Date of Event
- January 31, 2012
- Report Date
- February 15, 2012
- Manufacturer
- CUTERA, INC.
- Product Code
- GEX
- PMA / PMN Number
- K023954
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY DID NOT WANT TO PROVIDE TREATMENT INFORMATION. THE DATE OF THE TREATMENT IS UNKNOWN. THE LASER HAS BEEN EVALUATED AND REPAIRS COMPLETED FOR SEPARATE, UNRELATED ISSUES.
Description of Event or Problem · 1
"KELOID SCAR" DEVELOPED AFTER LASER HAIR REDUCTION TREATMENT TO "AXILLA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XEO 1064NM ND: YAG LASER | XEO 1064NM ND: YAG LASER | GEX | CUTERA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |