NATURALASE PIQO4
Received Feb 1, 2018
Report 1720381-2018-00001 · MDR key 7233380
Device
Generic name
Naturalase Piqo4
Manufacturer
Focus Medical, Llc.Model number
PIQO4Catalog number
GA-4000000
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn, Thermal
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING:"SKIN APPEARED ABLATED IN PHOTO OVER AREA'S TREATED. ENERGY SETTINGS APPEARED TOO HIGH AND IRREGULAR PATTERN OBSERVED. DENSE FROSTING OBSERVED IN OTHER AREA'S OF ENDPOINT. PT TREATED WITH HYDROGEL CREAM AND IS RECOVERING". BASED ON INFORMATION ABOVE AN ADVERSE EVENT HAD OCCURRED. LUMENIS IS NOT THE MANUFACTURER OF THE PIQO4 WHICH WERE BEING USED DURING THIS PROCEDURE, LUMENIS IS FORWARDING THE INFORMATION OF THIS EVENT TO THE LEGAL MANUFACTURER, FOCUS MEDICAL FOR FURTHER INVESTIGATION AND CLOSING THIS COMPLAINT.
Description of Event or Problem
A LUMENIS CLINICAL TRAINER REPORTED THAT ONE (1) PATIENT SUSTAINED BURNS ON HEAD AREA FOLLOWING TATTOO REMOVAL TREATMENT WITH A PIQO4 LASER.