This is the same event and the same patient reported under mdr id # 2939859-1999-00102.
This second mdr is being submitted for the second suspect product, also a device manufactured by collagen corp.
This separate distinct number is provided per the fda's request for traceability purposes.
A physician reported a patient who was treated on 29 march 1999 in the nasolabial folds, oral commissures, and upper and lower vermilion borders 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 bruised and painful and the patient 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 patient had difficulty eating/laughing.
The physician prescribed valtrex prophylactically, 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 approx 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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