This is the same event and the same pt reported under mdr id# 2939859-1999-103.
This is the first mdr submitted for the first suspect product.
A physician reported a pt who was treated on 29 march 1999 in the nasolabial folds, oral commissures, and upper and lower vermilion boreders with two formulations of product.
There was no sudden blanching or dramatic color change noted at time of treatment.
Within 8 hours, the right upper oral commissure treatment site became "purple" and the same night the area became painful.
On 30 march 1999, the area was brusied and painful and the pt self-medicated with advil "around the clock.
" on 31 march 1999, the blueness extended from the treatment site up to the nose and down to the jaw line and remained painful.
The physician prescribed nitroglycerine and temovate creams, and oral duricef.
On 1 april 1999, the area was slightly swollen, painful, and the pt had difficulty eating/laughing.
The physician prescribed valtrex prophalactically, and prescribed hydrogen peroxide to clean the area.
On 4 april 1999, the right oral commissure area was pink and the "blueness" had resolved.
On 6 april 1999, the area was improved.
On 8 april 1999, a "red and raw", dime-size area was beginning to slough; in the middle was a "hole" the size of the tip of a q-tip and which was forming a scab.
The area surrounding the "red raw" area was pink and approximately 1/2 dollar in size.
On 12 april 1999, the scab had resolved and there was a small "pin-point" open area with yellow colored drainage.
The physician believed the symptoms were related to a necrosis.
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