FDA Adverse Event
Other
Summary report: N
ELITE MPX
MDR report key: 3391047
·
Received October 3, 2013
Report
- Report Number
- 1222993-2013-00007
- Event Type
- Other
- Date Received
- October 3, 2013
- Date of Event
- August 29, 2013
- Report Date
- September 24, 2013
- Manufacturer
- CYNOSURE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K034030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PHYSICIAN REPORTED THAT A PATIENT RECEIVED A SCAR AFTER A TREATMENT FOR HAIR REMOVAL. PATIENT WAS SKIN TYPE III/IV. LASER WAS EVALUATED BY SERVICE AND FOUND TO BE OPERATING IN SPECIFICATION. POSSIBLE ROOT CAUSE IS USER ERROR DUE TO OVER TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
PATIENT EXPERIENCED A SCAR AFTER HER THIRD TREATMENT FOR HAIR REMOVAL. DOCTOR REPORTED AN ACUTE POST-TREATMENT RESPONSE DURING COOLING. THIS INCIDENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499192 | ELITE MPX | DERMATOLOGY LASER SYSTEM | GEX | CYNOSURE, INC. | ELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |