THERMISMOOTH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for THERMISMOOTH manufactured by Almirall Company.

Event Text Entries

[44723748] I had radiofrequency treatments with thermismooth, 4 treatments total between (b)(6) 2015. I had 2 more in (b)(6) 2015. On (b)(6) 2015, i had a treatment of ipl and an ablative laser by alma lasers. What occurred by (b)(6) 2016 is a loss of fat in temples, cheeks and under eyes and by nose continues. Hollows much more severe than when i began, have doubled (triple) bags now. Permanent discoloration under right eye and indentation under right eye. Skin is dry and tight, lost glow, skin texture is different, especially around the temples. Face is flattening, right side has less fat than left side. Facial integrity has changed. Eyes are getting smaller, lost lid space, lost waterline, it shrunk. Created more wrinkles under eyes as bags deflated originally. Now have bags and all the other issues too. Deeper marionette lines around mouth. Since 2 months ago, have observed mouth appears to be asymmetrical, look like a stroke victim. Can see it both in person and in pictures. Went on lexapro and started therapy in (b)(6) due to complete anxiety of negative facial changes. Asked five times before procedure if fat could be lost in face and if eyes could get smaller. I was reassured that if could not happen and even after the sixth treatment, was told it could not happen even though i was observing the above symptoms except for the mouth asymmetry. Four treatments were administered in early 2015 and 2 more were administered one month apart in (b)(6) 2015. By end of (b)(6), i noticed changes in my eyes and structure around my eyes. Complained to aesthetician, (b)(6), about changes. She assured me that the changes i described couldn't happen. I had ipl and ablative laser done on (b)(6) 2015 with traumatic results, particularly around my right eye. Massive swelling around eyes, very red face, had to come in for second ice mask. Face felt hot for more than 5 days. In (b)(6), after the swelling went down, end of 2nd week, i noticed depressions in my face; the change in eye hollows, smaller eyes and horrible veins on my face (redness that the doctor indicated was rosacea). The fat atrophy and shrinking of skin, eyes and mouth have continued for months. So many people prior to (b)(6) 2015 though i was 10-15 years younger than i am. Not anymore. I complained again to the (b)(6) clinic who performed the procedures. (b)(6) said if i had asked her before purchasing the package, she would have advised me against it. She said that to me in (b)(6) 2016 after i had completed my sessions and started to complain about adverse reactions. The owner's ((b)(6)) reaction was that i was having a mid-life crisis. She asked me how old i was even though we had discussed my age every time i saw her for injections in 2015. She told me that my face could change that dramatically in six months to a year. I told her i thought the thermi and perhaps ipl created the issues i mentioned above. She stated that it couldn't, that the temperature for the face could never lead to fat atrophy. My face has been impacted and i have numerous data points that can prove this happened not only to me but to others. See http://iplandlaserdamagesupport. Prophpbb. Com. ; article: complications in lasers, lights and radiofrequency devices; (b)(6); naief alnomair, rachel nazaian and ellen marmur, mds; (b)(6). Com/treatment/radiofrequency/the cosmetic guru; (b)(6). Com said: possible risks and complications, (b)(6) md and dr. (b)(6) also have remarks on (b)(6). Com and their own websites explaining the impact of radiofrequency and ipl/laser issues. Rx med: was not using any at the time of the procedures. Had therismooth on face, 6 treatments total in 2016; had ipl and ablative laser (by alma lasers) in (b)(6) 2015 and some microneedling in early 2015.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062113
MDR Report Key5636678
Date Received2016-05-03
Date of Report2016-05-03
Date of Event2015-12-21
Date Added to Maude2016-05-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 NameTHERMISMOOTH
Generic NameTHERMISMOOTH
Product CodePBX
Date Received2016-05-03
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALMIRALL COMPANY


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-05-03

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