FDA Adverse Event
Malfunction
Summary report: N
ELITE+ LASER SYSTEM
MDR report key: 5429131
·
Received February 10, 2016
Report
- Report Number
- 1222993-2016-00007
- Event Type
- Malfunction
- Date Received
- February 10, 2016
- Date of Event
- January 13, 2016
- Report Date
- February 10, 2016
- Manufacturer
- CYNOSURE INC
- Product Code
- GEX
- PMA / PMN Number
- K141425
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT WAS GIVEN MEDICATION [ACRIFLEX] FOR PREVENTATIVE CARE AND RECEIVED MEDICAL INTERVENTION FROM DERMATOLOGISTS. TREATMENT PARAMETERS WERE WITHIN RECOMMENDED GUIDELINES. DEVICE OPERATED OUT OF SPECIFICATION, SUSPECTED TO BE ABOVE 20% OF THE NOMINAL ENERGY; SO TECHNICIAN MADE REPAIRS TO THE SYSTEM. THIS IS REPORTABLE DUE TO DEVICE MALFUNCTION AND PATIENT RECEIVED MEDICAL INTERVENTION.
Description of Event or Problem · 1
PATIENT RECEIVED MEDICAL INTERVENTION AFTER DEVELOPING SCAR ON FOREHEAD FROM A LASER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84307 | ELITE+ LASER SYSTEM | ELITE+ | GEX | CYNOSURE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |