SCITON LASER SYSTEM SCITON PROFILE (UNSURE AT MED OFFICE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for SCITON LASER SYSTEM SCITON PROFILE (UNSURE AT MED OFFICE) manufactured by Sciton Inc..

Event Text Entries

[74826979] Bbl photofacial for blood vessels, face red and swollen for about 2 - 3 weeks, loss the ability to sweat and no oil or moisture in face. Skin burns around the eyes and mouth area, skin loss volume in cheeks and chin and eyes. Muscles in cheeks ache, spider veins and facial veins came to the surface (resulting in red face) pot marks and pores all over face. Bumpy, orange peel skin. The chin was scarred with 2 burn holes. Dry uncomfortable skin. Hair loss at hair line on right side of forehead. Loose, lined skin that happened until 1/2 month after treatment. Symptoms continue to worsen to this day. Sensitivity to heat or cold with hot flushing during activity. Eyes are dry and sensitive. Red and white pigmentation over face. Weird, crawling and pulsing feeling in lips and cheeks. I believe there is nerve damage, also mushy feeling in cheeks, loss all firmness, skin is uncomfortable at all times. The plastic surgeon told me there was no risk and was perfectly sore when i asked the side effects and risks. He told me it would only go through the top few layers of skin. I believe i would still have sweat glands if that happened (and hair). The assistant told me that my skin would be even and would be soft and smooth, when i asked her if it could hurt my skin. Of course, they both said no. Following the treatment my skin felt like sandpaper and to this day feels as if there are paper cuts all over it, including my eyes. I do believe this treatment should be more regulated and the persons preforming this should have to tell you of all risks! It is changing some lives for the worst. Also, i forget to mention after the treatment my nose came to a large blistered and the skin came off in the shower and blood came out of pores on it for about 15 mins. Also the 2 burns in chin drained liquid for 3 days, had to keep tissue with me at all times. Something needs to be done about this. So called safe, painless treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069626
MDR Report Key6553802
Date Received2017-05-05
Date of Event2016-12-30
Date Added to Maude2017-05-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSCITON LASER SYSTEM
Generic NameSCITON LASER SYSTEM
Product CodeONF
Date Received2017-05-05
Model NumberSCITON PROFILE (UNSURE AT MED OFFICE)
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSCITON INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-05

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