FDA Adverse Event
Other
Summary report: N
PEARL FRACTIONAL
MDR report key: 2434651
·
Received January 30, 2012
Report
- Report Number
- 2954354-2012-00004
- Event Type
- Other
- Date Received
- January 30, 2012
- Date of Event
- December 3, 2011
- Report Date
- January 30, 2012
- Manufacturer
- CUTERA
- Product Code
- GEX
- PMA / PMN Number
- K080530
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THERE IS AN ONGOING INVESTIGATION FOR THE ROOT CAUSE OF THE INCIDENT.
Description of Event or Problem · 1
"GRID PATTERN AND HYPERPIGMENTATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEARL FRACTIONAL | CUTERA ER:YSGG LASER HANDPIECE | GEX | CUTERA | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |