VIBRADERM UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-10 for VIBRADERM UNKNOWN manufactured by Vibraderm.

Event Text Entries

[2216658] I went to a (b)(6) run by a local plastic surgeon (and my doctor; i have used him for botox) to take advantage of a groupon offer for vibradermabrasion. I look at least 15 years younger than i am, had almost zero wrinkles and fitzpatrick iv skin. I always bragged i had my mother's (b)(6) skin; it was smooth and nearly poreless except on the sides of my nose. The vibradermabrasion was described as a gentle "microcirculation procedure" to gently brighten dull skin. My skin really wasn't dull, i just had a few small age spots on my cheek bones and minimal stippling on my upper lip from electrolysis in my youth. But i thought a little freshening up at a high end spa would be good. Prior to the procedure, the aesthetician interviewed me and i gave her chapter and verse about my delicate skin. She did not warn me of any possible risks or adverse effects from the procedure. She told me my skin was very, very good. The procedure was uncomfortable and unbeknownst to me at the time was stopped after seven minutes when it usually goes for eleven. The girl applied a light serum to my skin and told me it might burn a little. It did like fire, especially around my mouth. She said i could have another treatment in a month. I left the spa with my face hurting, knowing i would not have another treatment. That night and the following day my face was red and burning. It hurt but since i was not given any information about what to expect i assumed it would heal. But after three days, it had not calmed down. I returned to (b)(6) and saw a nurse who told me she was not worried, my skin looked beautiful except for around my mouth. She gave me some cream to put around my sore mouth. A week post treatment, my skin was still burning so i went to a dermatologist who said i had irritant dermatitis and erythema from the procedure. She gave me some cortisone ointment to use on my skin. My skin continued to burn and then i noticed what looked like scarring on my chin, upper lips and cheeks. I returned to the dermatologist (this was three weeks after the first dermatologist visit) and was told i had hyperpigmentation and permanently enlarged pores on my face. The next week, i returned to (b)(6) that performed the vibradermabrasion. I had a visiage analysis of my skin which revealed enlarged pores all over my face but especially on my chin and cheeks and nose and the hyperpigmentation. The nurse told me she had never seen this before from one vibraderm treatment and i had to see the plastic surgeon. My appointment is (b)(6). Meanwhile, my skin continues to burn, i am experiencing what looks like rosacea and more and more enlarge pores are appearing all over my face. I also have a shinny look to my complexion. There is light striation scarring on my chin and on the nasio labial area and again microscarring all over my face. I had perfect poreless skin. I have been permanently damaged by this device and the incompetent, obviously untrained person who operated it. This was advertised as a light microcirculation treatment to relieve dullness with no risk and no downtime.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022614
MDR Report Key2296541
Date Received2011-10-10
Date of Report2011-10-10
Date of Event2011-08-24
Date Added to Maude2011-10-17
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 Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVIBRADERM
Generic NameVIBRADERM
Product CodeGFE
Date Received2011-10-10
Model NumberUNKNOWN
OperatorOTHER
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerVIBRADERM
Manufacturer Address2100 N. HWY. 360 SUITE 1502 GRAND PRAIRIE TX 75050 US 75050


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2011-10-10

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