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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCITONPHOTOFACIAL, SCITON BBL

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SCITON PHOTOFACIAL, SCITON BBL   Back to Search Results
Event Date 11/20/2007
Event Type  Injury  
Event Description

I had two intense pulsed light/bbl treatments done on my face to lighten up the sun spots and pigmentation, melasma, resulting from pregnancy. Two months after the two treatments, (b)(6) 2007 and (b)(6) 2007, i began to scar all over my face. There are dents, ice pick marks, puckering of skin, pinpoint indentations and lines which go in all directions across my face. The pinpoint indentations have occurred linearly, as if they came from the ipl handpiece from which the bursts of light were issued. Now that it is four months after the second and last treatment, i continue to form dents and ice pick marks on my face. My face also looks like it has shrunken in that there is dramatically less fullness. I have not been on a diet; i am not losing weight. However, the "caving in" of my face is making me appear emaciated but only in the face. I attribute this entirely to the ipl treatment. I am concerned that these changes are permanent and want to know how long they will continue. What recourses do i have? my face was perfectly smooth before but now it is riddled with indentations and pock mark like/ice pick marks as well as larger dents from where fat/fullness of the face once was. Something must be done about ensuring the procedure's safety and perhaps the manufacturers need to get involved and the estheticians need to be better trained. I am convinced that a lot of them do only what they need to do to get by and don't really appreciate the level of care that should be exercised doing these treatments. I am scarred and very angry. Dose or amount: #1 12 j, frequency: 515 filter; #2 11 j, 515 filter. (30 minutes) dates of use: #1. (b)(6)2007, #2 (b)(6) 2007. Diagnosis or reason for use: #1. Brown/macular areas and melasma. #2 brown/macular areas and melasma.

 
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Brand NamePHOTOFACIAL, SCITON BBL
Type of DeviceSCITON BBL
Manufacturer (Section F)
SCITON
palo alto CA
Manufacturer (Section D)
SCITON
palo alto CA
Device Event Key1000801
MDR Report Key1031650
Event Key990118
Report NumberMW5006326
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/16/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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