MAUDE Adverse Event Report: SCITON INC. SCITON LASER SYSTEM

Model Number SCITON PROFILE (UNSURE AT MED OFFICE)

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Hair Loss (1877); Nerve Damage (1979); Pain (1994); Swelling (2091); Hot Flashes/Flushes (2153); Discharge (2225)

Event Date 12/30/2016

Event Type  Injury  

Event Description

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.

• Brand Name: SCITON LASER SYSTEM
• Type of Device: SCITON LASER SYSTEM
• Manufacturer (Section D): SCITON INC.
• MDR Report Key: 6553802
• MDR Text Key: 74826979
• Report Number: MW5069626
• Device Sequence Number: 1
• Product Code: ONF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCITON PROFILE (UNSURE AT MED OFFICE)
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE; MULTI-VITAMIN
• Patient Age: 52 YR
• Patient Weight: 63