(B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF NERVE DAMAGE, DENT, HANGING WRINKLY SKIN, DISTRESSED, SKIN GOT INFLAMED AND DISFIGUREMENT ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING FOR THE REPORTED EVENTS: WARNINGS AND PRECAUTIONS: FOR TOPICAL USE ONLY. DO NO INJECT THROUGH THE TRANSFERRED GRID MARKINGS. DO NOT USE ON BROKE OR DAMAGED SKIN.
D
Patient 1
PATIENT REPORTED BEING INJECTED WITH KYBELLA BY A DOCTOR AND HAD BEEN LEFT WITH "NERVE DAMAGE WHICH IS NOT RESOLVING AFTER 6 WEEKS" AND "A DENT" ON THEIR NECK WITH "TWO BITS OF HANGING WRINKLY SKIN" THAT "WILL NEED COSMETIC SURGERY CORRECTION." PATIENT WAS DISTRESSED AND CLAIMED THAT THE PRODUCT HAS LEFT THE PATIENT WITH "DISFIGUREMENT." THE PATIENT NOTED THEY COULD NOT SMILE AND THAT THEIR "FACE SKIN GOT INFLAMED" AS WELL AS THEIR LIPS. PATIENT HAD GONE TO THE EMERGENCY ROOM WHICH INFORMED THE PATIENT OF HAVING NERVE DAMAGE. PATIENT NOTES THE SHAPE OF THEIR FACE IS DIFFERENT THAN BEFORE AND IS NOT BETTER. PATIENT STILL HAS ALL SYMPTOMS AND SAGGING SKIN. IT IS UNKNOWN IF THE SKIN GRID WAS USED.