Description of Event or Problem · 1
APPROX ONE YEAR AFTER TREATMENT WITH JUVEDERM ULTRA IN THE FOREHEAD AND NASOLABIAL FOLDS, THE PT EXPERIENCED SWELLING AND BLANCHING AT TREATMENT SITE. A HARD LUMP HAS REMAINED ON THE FOREHEAD, AND THERE IS WHITE SKIN DISCOLORATION. NO MEDICATION WAS PRESCRIBED. FOLLOW UP FINDINGS: THE PT STATES THAT A PHYSICIAN WHO IS NOT THE INITIAL TREATING PHYSICIAN NOTED THAT THE PRODUCT WAS INJECTED TOO SUPERFICIALLY AND NOTED A LUMP IN THE PT'S FOREHEAD AND NASOLABIAL FOLD. FOLLOW UP FINDINGS: RECENT FOLLOW UP WITH THE TREATING PHYSICIAN NOTES THAT THE PT HAS NUMEROUS HEALTH ISSUES, HAS TAKEN MANY CONCOMITANT MEDICAL THERAPIES, AND IS NOT PSYCHOLOGICALLY SOUND. THE PHYSICIAN NOTED EDEMA AFTER TREATMENT WITH JUVEDERM ULTRA WHICH RESOLVED WITHIN A WEEK AFTER TREATMENT. THE PHYSICIAN STATED THE INJECTION MAY HAVE BEEN TOO SUPERFICIAL OR IS A POSSIBLE GRANULOMA, ALTHOUGH NO LAB TESTS WERE REPORTEDLY DONE. THE TREATING PHYSICIAN NOTES THAT ANOTHER PHYSICIAN ATTEMPTED TO REDUCE THE LUMP BY TAKING A NEEDLE TO IT. ALLERGAN WILL FOLLOW UP WITH THE PHYSICIAN WHO IS NOT THE TREATING PHYSICIAN FOR ANY ADD'L INFO. RECENT FOLLOW UP FROM THE TREATING PHYSICIAN NOTES THAT BLANCHING, EDEMA, AND PAIN HAVE RESOLVED. THE TREATING PHYSICIAN PRESCRIBED NO TREATMENTS.