FDA Adverse Event Other Summary report: N

PEARL FRACTIONAL 2790NM ER: YSGG LASER

MDR report key: 2470719 · Received February 17, 2012

Report

Report Number
2954354-2012-00007
Event Type
Other
Date Received
February 17, 2012
Date of Event
February 10, 2012
Report Date
February 17, 2012
Manufacturer
CUTERA
Product Code
GEX
PMA / PMN Number
K080530
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PERSISTENT GRID PATTERN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PEARL FRACTIONAL 2790NM ER: YSGG LASER GEX: PEARL FRACTIONAL ER: YSGG LASER GEX CUTERA NA NA

Patients

Seq Age Sex Outcome Treatment
1 48 YR Required Intervention