Revanesse Versa+ with Lidocaine 1.0 mL 40082Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10669808001014), received between Mar 25, 2021 and Dec 13, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Use of Device Problem; Use of Device Problem

  ADVERSE EVENT INFORMATION: BASED ON THE INFORMATION PROVIDED, THE MEDICAL DOCTOR INJECTED HERSELF ON (B)(6) 2019, WITH REVANESSE VERSA + (W/ LIDOCAINE) 1.0ML PN40082, LOT # 19F071 IN THE LEFT AND RIGHT JAW AREA WITH I SYRINGE INJECTED PER SIDE (1.0ML VOLUME PER SIDE). INJECTOR IN THIS CASE AS MENTIONED IS THE MEDICAL DOCTOR MD, 20 YEARS EXPERIENCE. TOPICAL ANAESTHETIC BLT WAS USED. NO MEDICATIONS BEFORE TREATMENT. THE DOCTOR REPORTS EXPERIENCING REDNESS AND UNRESOLVED BUMPS ON THE LEFT SIDE OF HER FACE THAT PERSISTS 3 YEARS LATER. RIGHT SIDE IS UNAFFECTED. CLINIC HAD PROVIDED PROLLENIUM WITH PHOTOGRAPHS OF THE ADVERSE EVENT ON REQUEST. WHEN MANUFACTURER REACHED OUT FOR FURTHER INFORMATION ON PATIENT STATUS, DOCTOR REPORTED THAT BUMPS HAVE REDUCED BUT STILL SHOWING. CLINIC HAD PROVIDED PROLLENIUM WITH PHOTOGRAPHS OF THE ADVERSE EVENT ON REQUEST. THE MANUFACTURER INITIATED THE INVESTIGATION BY CONDUCTING A REVIEW OF ITS INTERNAL RECORDS ASSOCIATED WITH THE BATCH. IN ADDITION, A REVIEW FROM THE COMPANY'S MEDICAL DIRECTOR WAS SOUGHT. INTERNAL REPORT NUMBER (B)(4).

  Patient problems: Wrinkling

  MAUDE report 15974325 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML INTO THE LIPS AREA OF THE PATIENT ON (B)(6) 2020. AMOUNT OF PRODUCT INJECTED WAS 1 CC, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE, CAUCASIAN; DATE OF BIRTH: (B)(6) 1978. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS REPORTEDLY EXPERIENCING SWELLING, LUMPS AND REDNESS ONE WEEK POST INJECTION. PATIENT WAS PRESCRIBED MINOCYCLINE AND PREDNISONE PACK AS PER PATIENT'S REQUEST. PATIENT THEN STATED SHE WOULD NOT TAKE THE MINOCYCLINE RIT STOMACH UPSET - OFFERED ALTERNATIVE ANTIBIOTIC - PATIENT REFUSED. PATIENT WAS OFFERED TO DISSOLVE FILLER AFTER THE PRESCRIPTION- PATIENT DECLINED. 18 MONTHS LATER, THE PATIENT CONTACTED THE INJECTOR AFTER SPEAKING WITH A REPRESENTATIVE FROM ANOTHER FIELD WHO TOLD THE PATIENT THAT SHE SHOULD BE VERY CONCERNED ABOUT HER LIPS. PICTURES PATIENT SENT SHOW SLIGHTLY SUPERFICIAL FILLER IN LOWER LIP WHEN PATIENT PRESSES BOTTOM LIP AGAINST BOTTOM TEETH. AT REST, SAME AMOUNT OF LAXITY AS PRIOR TO INJECTION. PATIENT WAS OFFERED MULTIPLE TIMES TO DISSOLVE - THE PATIENT REFUSED. PATIENT STATES "JUST WANTS ANSWERS" AS TO WHY THIS HAPPENED. APPEARS TO BE UNT

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 14980929 ↗
• InjuryJul 8, 2021Therapeutic or Diagnostic Output Failure

  BASED ON THE INFORMATION PROVIDED FROM INJECTOR, PATIENT - FEMALE, (B)(6) Y.O., CAUCASIAN. NOT FIRST-TIME FILLER TREATMENT. ON (B)(6) 2021 - DATE OF TREATMENT WITH 1.5 SYRINGE OF REVANESSE VERSA+ 1.0 ML IN THE MENTALIST AREA OF THE PATIENT. PATIENT DID NOT HAVE ANY ADVERSE EVENTS. THREE WEEKS AFTER INITIAL TREATMENT, PATIENT WAS VERY MUCH SATISFIED. HOWEVER, ON (B)(6) 2021, REVANESSE VERSA+ FILLER IS COMPLETELY GONE FROM THE CHIN AS STATED BY PATIENT. PATIENT HAD SIMILAR REVANESSE VERSA FILLER TREATMENT IN APRIL 2019 IN LOWER ORBITAL AREA, HOWEVER, FILLERS HAVE RETAINED IN THAT AREA. THIS TIME FILLER DISAPPEARED IN A LITTLE MORE THAN A MONTH TIME. PATIENT RECEIVED COVID-19 VACCINE A MONTH BEFORE TREATMENT DATES. ACCORDING TO INJECTOR PATIENT DOES NOT HAVE ANY SIGNIFICANT MEDICAL HISTORY AS OF TREATMENT DATE. NKDA (NO KNOWN DRUG ALLERGIES).

  Patient problems: Insufficient Information

  MAUDE report 12139487 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION PROVIDED FROM INJECTOR, PATIENT - FEMALE, (B)(6), CAUCASIAN. NOT FIRST-TIME LIP FILLER TREATMENT. PATIENT HAD VARIOUS LIP FILLERS OVER THE COURSE OF FIVE YEARS. ON (B)(6) 2020 FIRST LIP TREATMENT. NO PROBLEMS. LIPS WERE PERFECT. ON (B)(6) 2021 LIP TREATMENT. NO PROBLEMS. LIPS LOOKED AND FELT PERFECT. ON (B)(6) 2021 WOKE UP AND LIPS WERE EXTREMELY SWOLLEN AND HURT, FELT LIKE A FEVER. ON (B)(6) 2021 TOP LIP SWELLING LESSENED BUT BOTTOM LIP STILL SWOLLEN AND LESS PAINFUL. ON (B)(6) 2021 LIPS LESS SWOLLEN AND NOT PAINFUL BUT SLIGHT BURNING LIKE CHAPPED LIPS CONTINUED TO SWELL SLIGHTLY OFF AND ON AND EXTREMELY DRY BUT NOT AS BAD UNTIL. ABOUT (B)(6). WOKE UP THAT MORNING AND WERE EXTREMELY SWOLLEN AND STAYED THAT WAY FOR SEVERAL DAYS. DURING THE NIGHT, THEY WERE HURTING A LITTLE. THEY HAVE JUST FINALLY RETURNED TO FAIRLY NORMAL BUT STILL FEEL LIKE THEY ARE BURNING. PICTURES SENT TO NURSE SINE THEY WERE UNCOMFORTABLE. SWELLING ON AND OFF, HOWEVER, DID NOT GO DOWN COMPLETELY BUT JUST LESS SWOLLEN SOME DAYS. PATIENT'S LIPS ACHED ALL THE TIME. PATIENT REPORTED THAT SHE WAS GIVEN COLD COMPRESS, BENADRYL (FIRST TWO NIGHTS) AND PREDNISONE (20 MILLIGRAMS FOR ABOUT THREE

  Patient problems: Burning Sensation; Fever; Pain; Swelling/ Edema

  MAUDE report 12071680 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION PROVIDED, ON (B)(6) 2021, PATIENT WAS INJECTED WITH 0.2 OF THE SYRINGE INJECTED IN UPPER RIGHT CHEEK AREA, AS WELL AS LOWER RIGHT MOUTH AREA. AS REPORTED, WITHIN 2 MINS OF THE FIRST INJECTION SITE, PATIENT HAS HAD INSTANT SEVERE SWELLING. ALL OF FILLER INJECTED WAS DISINTEGRATED WITH HYLENEX DUE TO EXCESSIVE SWELLING AND EXTREME PAIN. PATIENT WAS TREATED WITH HYLENEX IN UPPER RIGHT CHEEK WHERE SWELLING WAS VISIBLE. FOLLOW UP TO INSURE SWELLING HAD SUBSIDED, NO CONTRAINDICATIONS NOTED AS OF (B)(6) 2021. PCN ALLERGY, NO OTHER KNOWN ALLERGIES. PREVIOUS DERMAL FILLERS: VOLUMA, ULTRA PLUS, RADIESSE, VOLBELLA, VOLLURE. PATIENT SINCE 2015, NEVER ANY TREATMENT ISSUES IN THE PAST WITH OTHER FILLERS SHE RECEIVED, NOT ANY ADVERSE EFFECT WITH ANY OTHER SERVICES RECEIVED. BIRTHDATE (B)(6) 1971, CAUCASION, LIVES LOCALLY, OWNS SEVERAL RESTAURANTS. TOPICAL ANESTHETIC USED: LIDO 23% TETRACAINE. ANY MEDICATIONS AFTER OR BEFORE THE TREATMENT: HYLENEX, PREDNISONE, MOTRIN FOUR WEEKS BEFORE THE DATE OF REPORT, PATIENT HAS HAD COVID-19 MODERNA VACCINE MEDICAL DIRECTOR BEEN INFORMED OF THE AE. PATIENT WAS PRESCRIBED PREDNISONE AND GIVEN 500MG OF MOTRIN IMMEDIATELY POST HYLENEX TO

  Patient problems: Bruise/Contusion; Pain; Swelling/ Edema

  MAUDE report 11749025 ↗
• InjuryMar 25, 2021Device Slipped; Migration

  THE PATIENT INITIALLY REPORTED THE COMPLIANT TO THE MANUFACTURER. THE MANUFACTURE HAS REACHED OUT TO THE NURSE INJECTOR, WHO REPORTED THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ WITH 3-4ML MIDFACE, CHEEKS, TEAR TROUGHS, LIPS. THE NURSE REPORTS THE USE OF A TOPICAL ANAESTHETIC 23/7 LT PRIOR TO INJECTION. THE NURSE AND PATIENT HAS DETAILED THE FOLLOWING ADVERSE EVENTS OCCURRING IN (B)(6) 2020 PRODUCT SLIDING IN THE "CHEEK AND MID-FACE". INTERMITTENT AND NON UNIFORM SWELLING OF SPECIFIC AREAS OF THE LIPS PRIMARILY UPON WAKING. CASE WAS REVIEWED BY THE MEDICAL DIRECTOR WHO STATS THAT THE MIGRATION OF THE PRODUCT IS DUE TO INJECTION INTO A SUBOPTIMAL LOCATION OR SIGNIFICANT PRESSURE APPLIED TO THE AREA THRU RUBBING AND MASSAGING. LIP SWELLING IS MULTIFACTORIAL AND CAN BE CAUSED BY FOODS, DRUGS, TOPICALS AND EXCESS WATER OR SALT INTAKE, ESPECIALLY IF THERE IS ADDITIONAL HA IN THE LIP. THE MEDICAL DIRECTOR HAS EXPRESSED THAT HAVING REVIEWED THE IMAGES PROVIDED HE CANNOT SEE SIGNS OF NODULES, INFLAMMATORY REACTIONS, VASCULAR EVENTS, PRODUCT MIGRATION OR ALLERGIC REACTIONS. THEREFORE SEE NO CLINICAL OR PHOTOGRAPHIC EVIDENCE OF A PRODUCT ADVERSE EVENT.

  Patient problems: Swelling/ Edema

  MAUDE report 11570103 ↗