FDA Adverse Event
Other
Summary report: N
CUTERA TITAN
MDR report key: 791322
·
Received November 30, 2006
Report
- Report Number
- 2954354-2006-00001
- Event Type
- Other
- Date Received
- November 30, 2006
- Date of Event
- October 14, 2006
- Report Date
- November 30, 2006
- Manufacturer
- CUTERA, INC.
- Product Code
- ILY
- PMA / PMN Number
- k033768
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED. THERE WAS NO DEVICE MALFUNCTION THAT WOULD CAUSE THIS INJURY. PHYSICIAN HAD CONTINUED TO TREAT PATIENTS AFTER THE INJURY WITH NO ADDITIONAL ADVERSE EVENTS.
Description of Event or Problem · 1
PT WAS TREATED WITH TITAN AND REC'D SUPERFICIAL BURNS ON THE SUBMENTAL AREA. PT WAS TREATED ON FULL FACE AND NECK WITH NO PROBLEM. ADVERSE EVENT WAS REPORTED ONLY IN ONE AREA. EARLY PHOTOGRAPHS SHOWED PT WAS HEALING, BUT DUE TO NO FOLLOW UP PHOTOS OR INFO, IT IS UNKNOWN IF PT WILL HAVE ANY PERMANENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUTERA TITAN | INFRA RED DEVICE | ILY | CUTERA, INC. | XEO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |