QUANTEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-10 for QUANTEL manufactured by .

Event Text Entries

[3075509] From an ipl laser treatment for rosacea from a quantel prolite 2 machine on (b)(6) 2012, i experienced immediate swelling on the jaw line, both left jaw and right jaw. Worse on the left jaw. There was a little pain, but mostly for the first month or so after the injury i had numbness all along the jawline, which seems to indicate some kind of nerve damage. Around a month or 5 weeks after, the numbness started to be taken over by pain - as the numbness reduced it was replaced by pain. The pain was at times a good solid 3 or 4 on a scale of 10, since reduced to a 2 or 3. I saw an oral surgeon and was surprised to find out that oral surgeons also use cosmetic lasers. He knew exactly what i was talking about. His best guess was that the laser penetrated too deeply and caused an edema, and he also gave me the bad news that there may be scarring and that the swelling may be permanent. At this point, just over 3 months later, it is still a little numb, but mostly just hurts. The pain is normally in the 2-3 range, i. E. It's there, but i can stand it. The strangest sort of pain i've ever felt, sort of a warmth/burning/itching centered on the swelling, but also spreading back a little along the jaw. Really the strangest feeling, i like somethings corrosive and eating away in there. It feels as though it is actually on the jaw bone. Again, for the first month or so after the injury, there was more numbness than pain, then the numbness decreased as the pain increased. This was actually a relief, numbness is scarier than pain. The numbness is still there, a little worse further back on the jaw, although much better now, 3 months later. Shaving every day gives me an almost scientific test for numbness all over my face, i'm aware every morning that something is messed up on my left jaw. The two areas of swelling are still clearly visible, about an inch in length along the jawline, same location on both sides, although the left side is much worse. I look like i have jowls. I used to have a nice straight jaw line. The pain is subsiding a little, i have good days and bad days with it. I've had progress on the pain, but only a little progress on the swelling. I am afraid at this point that the swelling will be permanent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5027627
MDR Report Key2834865
Date Received2012-11-10
Date of Report2012-11-10
Date of Event2012-07-28
Date Added to Maude2012-11-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameQUANTEL
Generic NameQUANTEL PROLITE 2
Product CodeMVF
Date Received2012-11-10
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2012-11-10

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