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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PALOMARPALOMAR STARLUXIPL, PHOTOFACIAL

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PALOMAR PALOMAR STARLUX IPL, PHOTOFACIAL   Back to Search Results
Model Number NOT SURE
Event Date 03/04/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Had 1 ipl treatment done to my face at medspa, using the palomar starlux. Not sure what the settings were because when i asked a month later, i was told that was something shared between estheticians. They didn't even use goggles, just a piece of gauze over my eyes. The entire time the esthetician hurriedly zapped my face while she was trying to trying to sell me a series of laser hair removal. One week after treatment, i noticed small brown depressed scars under my eyes - one of the scars was where i had a small freckle, the other two i had no freckles there to begin with - and my skin was extremely dry. One and a half weeks after treatment i had 2 areas of small bumps on my forehead that looked crinkly. At 1st i thought this was part of the process and my skin would flake and heal itself. Four weeks after treatment, i went to the medspa to ask what happened to my forehead and to report strange sensations on the sides of my face that were almost numbing. I met with the head esthetician and was told that my damage was superficial, that she did not believe ipl could have caused it and that my series of treatments - 10 mild chem peels and 6 ipls - were nonrefundable even though i did not inquire about a refund. There was an air of attitude that i somehow caused this damage myself and was chided for not saying anything to my esthetician at my light chem peel 2 weeks after the ipl. I didn't say anything about the bumps or brown spots at my chem peel because i seriously thought that the changes were part of the process. She even said i could've had a reaction to the chem peel, but that is not true as i had a series of the same peels done in another state 5 years ago with great results and no adverse effects. I only wanted to find out what happened to my face and how to correct it. I was told that micro derms and peels could help or even more ipl, but i have not been back since for any additional treatments and am still paying for the treatments because i signed a contract. She also told me that the strange sensations must be hormonal or from seasonal changes - but that has never happened to me before - at 5 weeks after treatment, i started getting a shiny film on my face that would not come off, my skin quit sweating, and i started getting wrinkles under my eyes that extend down my cheeks to around my mouth when i smile. The wrinkles are so noticeable that a coworker mentioned it. I did not even ask her about my skin so it was an unprovoked comment. Even my husband can see the changes happening now. It has just kept getting worse and the skin on my left temple just looks so shiny and scaly that it does not even resemble skin. My skin is less firm and the quality of it gets worse by the week. I am scared that it will just keep getting worse and that i will never be able to get my old skin back. Dose or amount: sleek medspa would not tell me. Dates of use: 15 minutes; 2008. Diagnosis or reason for use: broken capillaries. Event abated after use stopped: no.

 
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Brand NamePALOMAR STARLUX
Type of DeviceIPL, PHOTOFACIAL
Manufacturer (Section F)
PALOMAR
82 cambridge st.
burlington MA 01803
Manufacturer (Section D)
PALOMAR
82 cambridge st.
burlington MA 01803
Device Event Key1014403
MDR Report Key1040345
Event Key998656
Report NumberMW5006787
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL NumberNOT SURE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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