Revanesse Lips+ with Lidocaine 1.0 mL 40144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10669808003025), received between Aug 26, 2021 and Nov 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2021Device Appears to Trigger Rejection; Migration

  BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON (B)(6) 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED IN THE LIPS AREA OF THE PATIENT. THE VOLUME INJECTED IS 1.0 ML. PATIENT IS (B)(6) . (DATE OF BIRTH: (B)(6)). NOT FIRST DERMAL FILLER TREATMENT. PATIENT HAS HAD RESTYLANE L, RESTYLANE KYSSE, VOLBELLA, AND VOLLURE IN THE LIPS BEFORE AND HAVE HAD DIFFERENT HA FILLED IN THE SAME AREA IN THE PAST WITH NO COMPLICATIONS. ACCORDING TO THE INJECTOR, PATIENT HAD NO PRE-EXISTING RISK FACTORS. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. ELEVATED FITZPATRICK SCALE: 2. MEDICATIONS AFTER/BEFORE THE TREATMENT: BIRTH CONTROL "ERRIN". PATIENT HAS BEEN VACCINATED WITH COVID-19 MODERNA VACCINE (1ST DOSE: (B)(6) 2021; 2ND DOSE: (B)(6) 2021). PATIENT RECEIVED A FLU SHOT ON (B)(6) 2021. NO OTHER SHOTS/MEDICATIONS AS REPORTED. TOPICAL ANESTHETIC USED: 2% LIDOCAINE INJECTED - DENTAL BLOCK + TOPICAL 23% LIDOCAINE/7% PRILOCAINE PATIENT IS SCHEDULED TO HAVE HYALURONIDASE. AS REPORTED BY INJECTOR, INJECTION IN LIPS USING THE PRODUCT WITH THE SYRINGE IN THE PACKAGING. LIDOCAINE, BOTH TOPICAL AND DENTAL BLOCK WAS USED FOR NUMBING. PRODUCT INJECTED IN BOTH UPPER AND LOWER LIPS. THE FULL SYRIN

  Patient problems: Deformity/ Disfigurement; Nodule; Swelling/ Edema

  MAUDE report 12853004 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON (B)(6) 2021 - DATE OF TREATMENT WITH 0.8 ML OF REVANESSE LIPS+ 1.0 ML PRODUCT IN THE LIPS AREA OF THE PATIENT. PATIENT DATE OF BIRTH IS (B)(6) 1989. FIRST TIME DERMAL FILLER USER. AS INITIALLY REPORTED, SWELLING QUICKLY, IMMEDIATELY APPEARED AFTER INJECTIONS. PATIENT WAS CHECKED FOR SIGNS OF VASCULAR OCCLUSION - NEGATIVE. CAPILLARY REFILL IS <3 SECONDS. PATIENT DENIED PAIN. AS REPORTED BY INJECTOR, DURING INJECTIONS, PATIENT'S LIPS STARTED TO SWELL SIGNIFICANTLY. INJECTIONS WERE STOPPED. CAPILLARY REFILL OF ALL 4 QUADRANTS OF LIPS WAS LESS THAN 3 SECONDS, NO BLANCHING OR OTHER SIGNS OF VASCULAR OCCLUSION. AS OF (B)(6) 2021, PATIENT IS RECOVERING. INJECTOR CONTACTED THE PATIENT LAST NIGHT AND PATIENT SAID THE SWELLING WAS DOWN SIGNIFICANTLY AFTER TAKING HER FIRST PREDNISONE TABLET. TOPICAL ANESTHETIC USED: COMPOUNDED BLT CREAM. ICE PACK WAS APPLIED. PATIENT WAS ADMINISTERED 180MG OF ALLEGRA OTC. A PRESCRIPTION FOR PREDNISONE 30MG PO QD X 3 DAYS WAS FAXED TO (B)(6) AND PATIENT TOOK HER FIRST PILL APPROXIMATELY ONE HOUR AFTER HER APPOINTMENT. NO MEDICATIONS TAKEN AFTER OR BEFORE TREATMENT. MEDICAL DIRECTOR HAS BEEN INFORMED OF ADVE

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12375121 ↗