FDA Adverse Event
Other
Summary report: N
FRAXEL
MDR report key: 2794993
·
Received October 3, 2012
Report
- Report Number
- 2954746-2012-00008
- Event Type
- Other
- Date Received
- October 3, 2012
- Report Date
- September 7, 2012
- Manufacturer
- SOLTA MEDICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K101490
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE COMPLAINT HANDLING DATABASE DID NOT SHOW ANY REPORT CONCERNING CANCER AFTER THE USE OF FRAXEL. SOLTA MEDICAL INC REQUESTED FEEDBACK FROM THE CONSUMER VIA (B)(4). BASED ON THE INFO CURRENTLY PROVIDED, THE REPORTED EVENT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
ON (B)(6) 2012, A COMMENT REGARDING FRAXEL WAS POSTED IN THE FRAXEL (B)(4). THE COMMENT WAS, "I GOT CANCER ON MY FACE STRAIGHT AFTER FRAXEL. I NEVER SUN BAKE. I AM A HERMIT THAT NEVER SEES THE SUN. PLEASE EXPLAIN?"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRAXEL | ELECTRO-SURGICAL UNIT AND ACCESSORIES | GEI | SOLTA MEDICAL, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |