REVANESSE LIPS+ (WITH LIDOCAINE)

Additional Manufacturer Narrative

PROLLENIUM MEDICAL TECHNOLOGIES (MANUFACTURER) HAS TRIED REACHING OUT TO THE INITIAL REPORTER FOR FURTHER INFORMATION HOWEVER THE CLINIC HAS NOT BEEN REPSONSIVE. NO FURTHER DETAILS WERE SHARED TO ALLOW MANUFACTURER TO CONDUCT AN INTERNAL INVESTIGATION. THE MANUFACTURER IS FILING AN INITIAL REPORT AND WILL CONTINUE FOLLOWING UP WITH THE CLINIC AND FILE A FOLLOW UP REPORT ONCE MORE DETAILS RELATED TO THE EVENTS ARE AVAILABLE.

Description of Event or Problem

INJECTOR HAD A PATIENT TREATED AT ANOTHER MEDSPA. CREATED A NODULE ON PATIENTS SKIN AND WHEN BIOPSIED IT CAME BACK AS SILICONE. FIRM NODULES UPPER AND LOWER MOUTH TREATED WITH HYALURONIDASE 5 TIMES NO RESOLUTION SO HE BIOPSIED AND SAW SILICONE. IT HAS LOT NUMBER AND EXPIRATION DATE AS 24K198 EXPIRES 2026-11-14 (NOVEMBER 14). CLINIC HAS SHARED NO FURTHER INFORMATION TO CONDUCT AN INTERNAL INVESTIGATION. INTERNAL COMPLAINT NUMBER: (B)(4).