FDA Adverse Event
Injury
Summary report: N
FRAXEL SR 750 LASER SYSTEM
MDR report key: 909619
·
Received August 27, 2007
Report
- Report Number
- 2950711-2007-00005
- Event Type
- Injury
- Date Received
- August 27, 2007
- Date of Event
- May 7, 2007
- Report Date
- August 24, 2007
- Manufacturer
- RELIANT TECHNOLOGIES
- Product Code
- GEX
- PMA / PMN Number
- K053047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS FULLY INSPECTED AT RELIANT TECHNOLOGIES AND FOUND TO MEET OR EXCEED ALL MFG SPECIFICATIONS.
Description of Event or Problem · 1
IN 2007, A PATIENT (FEMALE) WAS REPORTED TO HAVE UNILATERAL ULCERATION ON THE RIGHT CHEEK, SUBSEQUENTLY RESULTING IN A SCAR, AFTER RECEIVING A SINGLE TREATMENT WITH THE FRAXEL SR 750. THE TREATMENT WAS PERFORMED AT A SETTING OF 10 MJ/PULSE, 250 MTZ/CM2/PASS, FOR A TOTAL TREATMENT DENSITY OF 1490 MTZ/CM2. THE NEXT DAY, BIAFINE TOPICAL WAS APPLIED TO THE AFFECTED AREA AND FIVE DAYS LATER, CIPROFLOXACIN 500 MG WAS PRESCRIBED BUT NOT TAKEN BY THE PATIENT. THE TREATING PHYSICIAN CLASSIFIED THE RESPONSE AS A PERMANENT SCAN TWO MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRAXEL SR 750 LASER SYSTEM | NA | GEX | RELIANT TECHNOLOGIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention| S | CIPROFLOXACIN 500 MG| BACITRACIN 2-3X/DAY POST TREATMENT| PATIENT| BIAFINE TOPICAL |