FDA Adverse Event
Injury
Summary report: N
THE PALOMAR ASPIRE LASER PLATFORM
MDR report key: 2831759
·
Received November 9, 2012
Report
- Report Number
- 1223483-2012-00001
- Event Type
- Injury
- Date Received
- November 9, 2012
- Date of Event
- October 12, 2012
- Report Date
- November 9, 2012
- Manufacturer
- PALOMAR MEDICAL TECHNOLOGIES INC.
- Product Code
- GEX
- PMA / PMN Number
- 083165
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT BEING TREATED WITH PALOMAR'S ASPIRE LASER PLATFORM EXPERIENCED TWO FULL THICKNESS BURNS IN THE ABDOMEN AREA. ONE MEASURES APPROXIMATELY 3.5 CM X 1.5 CM AND THE OTHER IS SLIGHTLY SMALLER. PT IS EXPERIENCING SOME PAIN AND ANTIBIOTICS WERE PRESCRIBED FOR POSSIBLE INFECTION. PHYSICIAN PLANS ON RESECTING THE AFFECTED TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE PALOMAR ASPIRE LASER PLATFORM | MEDICAL LASER SYSTEM | GEX | PALOMAR MEDICAL TECHNOLOGIES INC. | 0320-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |