FDA Adverse Event
Injury
Summary report: N
NATURALASE PIQO4
MDR report key: 7233380
·
Received February 1, 2018
Report
- Report Number
- 1720381-2018-00001
- Event Type
- Injury
- Date Received
- February 1, 2018
- Report Date
- February 1, 2018
- Manufacturer
- FOCUS MEDICAL, LLC.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CT, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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 · 1
A LUMENIS CLINICAL TRAINER REPORTED THAT ONE (1) PATIENT SUSTAINED BURNS ON HEAD AREA FOLLOWING TATTOO REMOVAL TREATMENT WITH A PIQO4 LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78566 | NATURALASE PIQO4 | NATURALASE PIQO4 | GEX | FOCUS MEDICAL, LLC. | PIQO4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |