Description of Event or Problem · 0
BUMPS [INJECTION SITE MASS] OFF LABEL USE IN LIPS [OFF LABEL USE OF DEVICE]. THIS REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER VIA COMPANY REPRESENTATIVE ON (B)(6) 2025 AND CONCERNS A 63-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED BUMPS, COINCIDENT WITH EVOLYSSE FORM. THE PATIENT WAS INJECTED ON THE LIPS ON (B)(6) 2025 AND FELT LIKE SHE SHOULD LOOK BETTER WITH THIS PRODUCT THAN SHE DID. THIS WAS HER SECOND TREATMENT AS SHE RECEIVED EVOLYSSE SMOOTH ON (B)(6) 2025. THE PATIENT STATED THAT SHE RECEIVED EVOLYSSE FORM DUE TO HER BOTTOM LIP LOOKING LOPSIDED AND HER LIP WAS DROOPING. SHE STATED THAT SHE COULD FEEL BUMPS AND IT HAD BEEN TWO WEEKS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE LUMP WAS UNKNOWN. FOLLOW-UP INFORMATION RECEIVED ON 18-JUN-2025: THE PATIENT INDICATED THAT HER BOTTOM LIP LOOKED LIKE IT COULD USE MORE AND THE INSIDE OF BOTH LIPS, THE SIZE OF A COLD SORE, IT DID NOT HURT, JUST THE SIZE OR LARGE BUMPS, FELT LIKE MORE FILLER UNDERNEATH THAN ON HER LIP. FOLLOWING A DATABASE MIGRATION THE FOLLOW-UP SEQUENCE MAY HAVE REVERTED TO INITIAL FOR THE FIRST FOLLOW-UP POST MIGRATION. PLEASE NOTE THAT THIS IS MEDWATCH CASE VERSION FU#1. DATABASE REFERENCE NUMBER: (B)(4).