Revanesse Versa+ with Lidocaine 1.2 mL 40083Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10669808001038), received between Feb 1, 2021 and Nov 12, 2025 — classified as 65 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 reports).

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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED REVANESSE VERSA + (W/ LIDOCAINE) (LOT 241123) IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES VIA MICROCANNULA ON (B)(6) 2025. WAS FINE UP UNTIL EARLY (B)(6) 2025; SHE NOTICED SUDDEN ONSET OF PALPABLE NODULE DEVELOPMENT ON THE AREAS TREATED. THE NODULES ARE PALPABLE, NON-TENDER, AND NON-ERYTHEMATOUS. PATIENT WAS OFFERED TO RESOLVE PRODUCT BUT WANTED TO HOLD OFF SINCE SHE DOES LIKE THE RESULTS NOT JUST THE PALPABLE NODULES.

  Patient problems: Nodule

  MAUDE report 23533999 ↗
• InjuryOct 30, 2025Use of Device Problem; Use of Device Problem

  THE EVENT OCCURED ON AUGUST 19TH. THE EVENT WAS REPORTED TO PROLLENIUM MEDICAL TECHNOLOGIES INC. ON 01-OCT-2025. AS PER THE PATIENT: THE LOT # FOR ONLY ONE OF THE PACKAGES THAT SHE PUT IN MY LIP IS 24E144 (FOR THE CONCERNS ABOVE THE LEFT LIP AND NEXT TO CORNERS OF LEFT LIP AND UNDER THE LEFT LIP, AND ALL AROUND THE RIGHT LIP AS WELL ), HOWEVER I DON'T HAVE THE LOT # FOR THE REVANESSE VERSA VIALS/PACKAGE THAT CAUSED THE MOST EXTREME ADVERSE REACTIONS (ON THE ENTIRE RIGHT SIDE OF MY FACE INCLUDING NEXT TO MY EYES AND NOSE AND ON THE LEFT SIDE OF MY JAWLINE+UNDER IT) SUMMARY OF MY FIRST EXPERIENCE WITH REVANESSE VERSA (WHICH THE INJECTOR KEPT ON RECOMMENDING FOR MY RIGHT UNDER EYE, LEFT SIDE ONLY OF CHIN AND LIPS) INJECTED ON (B)(6) 2025 BY MED SPA IN DARIEN CT: FIRST - I ASKED FOR ONLY UNDER EYE FILLER ON THE RIGHT SIDE OF MY FACE - THE INJECTOR USED A CANNULA AND MADE SEVERAL ENTRY POINTS IN MY RIGHT CHEEK AND TOLD ME THE FILLER WOULD BE GOING TO MY UNDER EYE AND NOT MY CHEEKS HOWEVER THE FILLER STAYED THERE IN MY RIGHT CHEEK AND TURNED INTO BIG BUMPS , THE INJECTOR THEN AGGRESSIVELY MASSAGED THE BUMPS IN THE DIRECTION TOWARDS MY EYE THEN FOR ONLY THE LEFT SIDE OF MY CHIN WHICH IS A

  Patient problems: Inflammation

  MAUDE report 23429405 ↗
• InjuryJun 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT INFORMATION: THE PATIENT IS A 47-YEAR-OLD CAUCASIAN FEMALE CLAIMING: "(B)(6) INJECTED ME WITH SILIKON 1000 IN 2012 AND 2013 IN THE SAME ACNE SCARS, SO I TRUSTED HIM WHEN HE TOLD ME THAT (B)(6) OVER SILIKON WAS PERFECTLY SAFE. WELL, I'VE COME TO FIND OUT, THAT IS NOT THE CASE. I HAD A SEVERE INFLAMMATORY RESPONSE TO THIS". ADVERSE EVENT INFORMATION: FOLLOWING THE INITIAL INJECTION, THE PATIENT MOSTLY EXPERIENCED SOME LUMPS AND DISCOLORATION WHICH SHE THOUGHT WAS NORMAL. SHE ALSO EXPERIENCED CALF PAIN BUT DIDN'T CONNECT IT TO THE HA FILLER AT THE TIME. THE CALF PAIN WAS PERSISTENT FOR SEVERAL MONTHS UNTIL SHE BEGAN DISSOLVING AND WENT ON PREDNISONE. IT STILL IS NOT COMPLETELY GONE. SHE BROUGHT UP THE DISCOLORATION TO THE DOCTOR AND HE DISMISSED IT SO SHE COUGHED IT UP TO A BRUISE BUT AFTER MORE RESEARCH FOLLOWING THE SECOND SET OF INJECTIONS, SHE REALIZED IT WAS TOO LONG FOR A BRUISE TO LINGER. (B)(6), INSTEAD OF TAKING PAUSE TO HEAR WHAT SHE WAS SAYING (THAT WAS THE START OF THE GASLIGHTING), HE PROCEEDED WITH THE SECOND SET OF INJECTIONS SIX WEEKS LATER WHICH ONLY EXACERBATED EVERYTHING. SHE EXPERIENCED PERSISTENT SWELLING, VISIBLE LUMPS, DISCOLORATION, SMILE DISTORTION, CA

  Patient problems: Nodule; Skin Discoloration

  MAUDE report 22153915 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INJECTOR, PA-C, A 35-YEAR-OLD FEMALE PATIENT WAS INJECTED WITH 0.2 ML OF REVANESSE VERSA+ INTO HER TOP RIGHT UPPER LIP. THE PATIENT HAD A HISTORY OF LIP SORES AND TOOK VALTREX BEFORE THE INJECTION. THE INJECTOR ASPIRATED BEFORE EACH INJECTION & SHOWED GOOD CAPILLARY REFILL AFTER INJECTION. THE INJECTOR ASKED IF PATIENT WAS IN PAIN, PT. SAID THERE WAS PAIN BUT NOT INTENSE. ON DAY 2, THE PATIENT EXPERIENCED INTENSE PAIN (9/10). THE RIGHT UPPER LIP'S VERMILION BORDER DEVELOPED A HEMATOMA. THE PATIENT WAS REFERRED TO DR. SAYEED IN PLASTICS, WHO USED TWO VIALS OF HYLENEX TO FLUSH OUT A POSSIBLE VASCULAR OCCLUSION (VO). ON DAY 3, THE PATIENT REPORTED BLURRY VISION, AND A CTA OF THE HEAD AND NECK CAME BACK NORMAL. BY DAY 4, THE PATIENT HAD BRUISING EXTENDING ABOVE THE LIP, WITH NORMAL PAIN AND SENSATION. BRUISING PERSISTS. THE PLASTIC SURGEON SUSPECTS THIS MAY BE A CASE OF VASCULAR OCCLUSION IN THE UPPER LIP. THE PT. GOT A SECOND OPINION BY DR. (B)(6) IN (B)(6); WHO DIAGNOSED HER WITH ECCHYMOSIS. THE INFORMATION PROVIDED BY THE CLINIC AND THE PATIENT HAS BEEN SUBMITTED TO THE PROLLENIUM'S MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS

  Patient problems: Easy Bruising; Pain

  MAUDE report 21943791 ↗
• InjuryApr 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CAME IN REQUESTING LIP FILLER. INJECTOR ADVISED SHE DISSOLVE, BUT PATIENT REQUESTED JUST ENOUGH TO ADD HYDRATION. INJECTOR USED .2CC ON REVANESSE LIPS+ ON TOP RIGHT PILLOW ON LOWER RIGHT PILLOW AND ADDED .1CC TO PIRIFORM FOSSA ON EACH SIDE. PATIENT CALLED LAST NIGHT SAYING SHE HAS HAD BURNING SENSATION SINCE INJECTION (ONE MONTH PRIOR IE. (B)(6) 2025). SHE DID NOT REPORT BECAUSE SHE THOUGHT IT WOULD IMPROVE, BUT HER LIPS STILL BURN, AND SHE HAS SOME PAIN WHEN APPLYING CHAPSTICK. PATIENT FEELS SHE IS SEEING SOME WHITENESS, BUT PROVIDER BELIEVES BEFORE AND AFTER COLOR IS CONSISTENT BASED ON PHOTOS (NOT PROVIDED BY THE CLINIC). EVENT REPORTED ON 28-MAR-2025. INTERNAL REPORT NUMBER: CCR-C-2512.

  Patient problems: Discomfort

  MAUDE report 21921911 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED THE INJECTION ON (B)(6) 2024. SUPERFICIAL MIGRATION OF FILLER OBSERVED 6+ MONTHS POST TREATMENT WITHIN WET TO DRY BORDER ON UPPER LIP. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21201900 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED THE INJECTION ON (B)(6)2024. ONE SYRINGE WAS SPREAD OUT IN THE NASOLABIAL FOLDS AND MARIONETTE LINES. PUFFINESS/REDNESS LASTED LONGER AND GOT WORSE, THEN ITCHY FROM DATE OF INJECTION. LASTED FOR ONE WEEK. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 21143557 ↗
• InjuryJan 10, 2025Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  AS PER AN ADVERSE EVENT REPORT RECEIVED ON FRIDAY, (B)(6) 2024, A FEMALE PATIENT (PT) EXPERIENCING ALLERGIC REACTION, VERY SWELLING LIPS FOLLOWING AN INJECTION OF 1.2 ML OF REVANESSE VERSA+ INTO HER LIPS BY AN INJECTOR, NP ON (B)(6) 2024. THE PT HISTORY SHOWS THAT SHE HAD BEEN TREATED WITH JUVDERM WITH NO ISSUES. NO INFORMATION ABOUT THE PATIENT (PREVIOUS MEDICAL HISTORY), INJECTION (INJECTION PLAN), ADVERSE EVENT (DETAILS AND TIMELINES) AND POST CARE HAS BEEN PROVIDED DESPITE OF SEVERAL REQUESTS BY PROLLENIUM THROUGH EMAIL [(B)(6)2024, (B)(6)2025]. THE PROVIDED IMAGES OF THE PATIENT LIPS DO NOT HAVE TIME STAMPS INFORMATION. THE BATCH RECORD, QC TEST REPORTS, AND QC FINAL INSPECTION REVIEW CHECK LIST WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 24H025 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM'S MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A CLINI

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130414 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING NP'S ACCOUNT: "SLIGHT DISCOLORATION NOTED AT INJECTION AREA OF PYRIFORM FOSSA AND NOSE. PT DISSOLVED DAY OF INJECTION. FURTHER DISSOLVED NEXT 2 DAYS. MEDS PRESCRIBED: MEDROL, CLINDAMYCIN, KEFLEX, ASA, VIAGRA, NITROPASTE AND WARM COMPRESSES USED. AS OF (B)(6) CLIENT REPORTS IT HAS RESOLVED. UNSURE IF THIS WAS A VASCULAR COMPRESSION VS OCCLUSION. NO SPECIFIC SITE FOUND IMPAIRING BLOOD FLOW ON 2 DIFFERENT ULTRASOUNDS." PROLLENIUM MEDICAL TECHNOLOGIES INC.: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A PATIENT HAD REVANESSE VERSA+ INJECTED INTO THEIR NOSE AND PYRIFORM FOSSA. COMPOUNDED BLT TOPICAL ANESTHETIC WAS APPLIED PRIOR TO INJECTION. THE NP INJECTOR NOTICED "DISCOLOURATION" IN THE AREA OF INJECTION, SO THE AREA WAS TREATED AS A VASCULAR COMPROMISE AND THE PRODUCT WAS "DISSOLVED". THE DISCOLOURATION RESOLVED. NO OTHER HISTORY OR PHOTOS WERE PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A CASE OF VASCULAR OCCLUSION WHICH WAS TREATED SUCCESSFULLY BY DISSOLVING THE PRODUCT."

  Patient problems: Skin Discoloration

  MAUDE report 20727243 ↗
• InjuryNov 8, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024 A PATIENT RECEIVED 0.25 CC OF REVANESSE VERSA+ UNDER EACH EYE, IN THE MID PUPILLARY LINE. THE PRODUCT WAS PLACED ON THE "ORBITAL RIM". BLT COMPOUNDED TOPICAL ANESTHETIC WAS APPLIED TO THE AREA PRIOR TO INJECTION. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME UNSPECIFIED LATER DATE THE PATIENT COMPLAINED OF SWELLING UNDER THE EYES. THERE WERE NO NODULES, ERYTHEMA OR INFLAMMATION. NO PHOTOS WERE PROVIDED. THE PRODUCT AND AREA WAS TREATED WITH HYLENEX AND RF MICRO NEEDLING. MY CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED, IS THAT THIS CASE REPRESENTS SUBOPTIMAL PRODUCT SELECTION AND PLACEMENT. THERE IS NO HISTORY OF PRODUCT AES. THE PATIENT'S DISSATISFACTION WAS TREATED BY DISSOLVING THE PRODUCT. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 20636893 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA+ INTO HER LIPS AND MARIONETTE LINES. TOPICAL ANESTHETIC WAS APPLIED, BEFORE THE INJECTION, TO THESE SAME AREAS. THERE IS NO HISTORY OF WHAT POST PROCEDURE PRODUCTS WERE BEING APPLIED TO THE AREAS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. FIVE WEEKS LATER THE PATIENT NOTIFIED THE INJECTOR THAT TWO DAYS AFTER THE INJECTIONS SHE EXPERIENCED "IRRITATED FLAKY SKIN" OVER HER MARIONETTE LINES. THERE WAS NO REACTION ON THE LIPS. THE PATIENT WAS SEEN AT A WALK-IN-CLINIC AND TREATED WITH STEROIDS. IT WAS NOT REPORTED IF THIS WAS ORAL OR TOPICAL STEROIDS. NO CLINIC DIAGNOSIS WAS PROVIDED. THERE WAS NO HISTORY OF NODULES OR VASCULAR COMPROMISE. AFTER THE STEROID TREATMENT WAS COMPLETED THE FLAKY SKIN REOCCURRED, SO THE INJECTING PHYSICIAN DISSOLVED THE PRODUCT IN THE MARIONETTES WITH HYLENEX. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A CONTACT DERMATITIS OR PERIORAL DERMATITIS. THESE ARE USUALLY CAUSED BY PRODUCTS APPLIED TO THE SKIN. THE FACT THAT THERE WERE NO INFLAMMATORY NODULES OR SKIN REACTIONS ON THE LIPS MAKES IT LESS LIKELY THAT THE HA FILLER WAS THE SOURCE OF THE PATIENT'S FLAKY SKIN. INTERN

  Patient problems: Contact Dermatitis

  MAUDE report 20523374 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT SOME TIME APPROXIMATELY 27 MONTHS EARLIER AT PATIENT RECEIVED " REVANESSE VERSA" (UNCONFIRMED AS NO LOT # WAS PROVIDED) INTO HER LIPS BY AN RN. THERE WERE NO RECORDED ADVERSE EVENTS OR CONCERNS. TWO YEARS AND 3 MONTHS LATER THE PATIENT NOTICED A SMALL NON INFLAMED RIDGE ON HER EVERTED, INNER, UPPER LIP. THE RIDGE WAS ON THE MUCOSA IN LINE WITH THE OCCLUSION OF THE TEETH. THE LINE EVEN HAD GAPS CORRESPONDING TO THE SPACES BETWEEN THE PATIENT'S TEETH. THE INJECTOR DESCRIBED THE PATIENT AS "UNDER STRESS". THERE WAS NO MEDICAL DIRECTOR DOCUMENTED ON THE AE NOTIFICATION FORMS WHICH SUGGESTS THE PATIENT DID NOT HAVE A MEDICAL ASSESSMENT FOR HER CONCERN. MY CLINICAL OPINION IS THAT THIS DOES NOT REPRESENT AN HAVE ADVERSE EVENT. THE LINE ON THE MUCOSA OF THE UPPER LIP IS THE CLASSIC APPEARANCE SEEN WHEN SOMEONE HABITUALLY BITES ONTO THEIR LIP. THIS IS A VERY COMMON FINDING AND OCCURS MORE OFTEN WHEN INDIVIDUALS ARE NERVOUS OR STRESSED. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Nodule

  MAUDE report 20286458 ↗
• InjuryAug 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML,21E014 ON (B)(6) 2022 ON THE VERSA, 0.3ML OF PRODUCT WAS INJECTED. THE PATIENT REPORTS TO THE INJECTOR THAT SHE HAS DEVELOPED BUMPS ON HER LIPS A YEAR LATER. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED.

  Patient problems: Nodule

  MAUDE report 19924214 ↗
• InjuryJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 A PATIENT RECEIVED 1.2 CC OF REVANAESSE VERSA+ INTO THEIR LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME LATER UNKNOWN DATE THE PATIENT FELT THERE WAS "SWELLING AND LUMPS" IN THEIR LIPS. THE PATIENT'S PHYSICIAN PUT THE PATIENT ON PREDNISONE WHICH RESOLVED THE SYMPTOMS. ON (B)(6) 2024 THE "SWELLING AND LUMPS" RETURNED. THE PATIENT WAS SEEN BY THE INJECTOR WHO DISSOLVED THE "AREAS OF CONCERN" WITH HYLENEX AND THE PATIENTS CONCERNS RESOLVED. DUE TO THE LACK OF MEDICAL INFORMATION IN THIS CASE, IT IS DIFFICULT TO PROVIDE AN ACCURATE CLINICAL OPINION. MY VIEW IS THAT THIS REPRESENTS A CASE OF SUBOPTIMAL LIP FILLING THAT RESULTED IN LUMPY DISTRIBUTION OF PRODUCT. THIS WAS EASILY RESOLVED WITH THE INJECTION OF HYLURONIDASE. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Nodule

  MAUDE report 19839570 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 30, 2024, A PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA+ INJECTED INTO THEIR LIPS. COMPOUNDED 23% LIDOCAINE WITH 7% TETRACINE WAS APPLIED TO THE LIPS PRIOR TO INJECTION. THE PATIENT WAS ALSO ON USINOPRIL ACE INHIBITOR FOR THE TREATMENT OF HYPERTENSION. THERE WERE NO CONCERNS OR ADVERSE EVENTS DOCUMENTED AT THE TIME OF INJECTION. PHOTOS PROVIDED SHOWED BRUISING IN BOTH LIPS HOWEVER THERE WAS MORE BRUISING IN THE UPPER LIP. FIVE (5) HOURS LATER THE PATIENT HAD MODERATE SWELLING IN THEIR UPPER LIP. THERE WAS NO PAIN, NO NODULES OR OTHER CLINICAL CONCERNS. THE PATIENT WAS GIVEN ZYRTEC AND ONE DOSE OF METHYLPREDNISOLONE AND THE SYMPTOMS COMPLETELY RESOLVED. THE HA PRODUCT WAS NOT DISSOLVED. MY CLINICAL OPINION IS THAT THIS REPRESENTS ANGIOEDEMA OF THE UPPER LIP TRIGGERED BY THE COMBINATION OF LIP TRAUMA (BRUISING) AND ACE INHIBITOR, WHICH IS WELL DOCUMENTED. TETRACAINE IS ALSO THE MOST ALLERGENIC TOPICAL ANESTHETIC AND COULD BE A CONTRIBUTING FACTOR. THE LOWER LIP DID NOT SWELL ( HA WAS INJECTED IN BOTH LIPS) AND THE REACTION SUBSIDED DESPITE THE FILLER NOT BEING DISSOLVED. IN MY OPINION THIS EXCLUDES HA FROM BEING THE CAUSE OF THE "ALLERGIC REACTION". INTERNAL REPORT NUMBER: (B

  Patient problems: Easy Bruising

  MAUDE report 19552797 ↗
• InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION/REPORT PROVIDED BY THE CLINIC, A FEMALE (THE DOB WAS NOT DISCLOSED) WAS INJECTED WITH REVANESSE VERSA+(WITH LIDOCAINE) IN LIPS ON (B)(6) 2023. AROUND OR AT (B)(6) 2024, THE PATIENT CONTACTED THE CLINIC AND REPORTED EXPERIENCING EXCESSIVE DRYNESS AND CRACKING LIPS. NO INFORMATION ABOUT THE PATIENT [RACE, PREVIOUS MEDICAL HISTORY), INJECTION (INJECTION PLAN, LOCATION, AMOUNT OF INJECTION, MEDICAL CONDITION OF PATIENT DURING THE INJECTION) AND POST CARE HAS BEEN PROVIDED DESPITE OF SEVERAL REQUESTS BY PROLLENIUM THROUGH EMAIL [6-FEB-2024, 12-FEB-2024,15-FEB-2024,20-FEB-2024,26-FEB-2024,29-FEB-2024], PHONE CALL AND SENDING A 30-DAY-NOTICE LETTER THROUGH EMAIL [29-FEB-2024]. NO IMAGES OF THE PATIENT LIPS AFTER AND BEFORE THE INJECTION HAVE BEEN PROVIDED. THE BATCH RECORD, QC TEST REPORTS (30-MAY-2023), AND QC FINAL INSPECTION REVIEW CHECK LIST (12-JUN-2023) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22H103 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROV

  Patient problems: Dry Skin; Tissue Breakdown

  MAUDE report 18856929 ↗
• InjuryFeb 23, 2024No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  A PATIENT RECOUNTED A NARRATIVE THAT THE SHE WAS INJECTED WITH REVANESSE VERSA. HER ACCOUNT INDICATED THAT SHE WAS TREATED IN THE MARIONETTE LINES, NASOLABIAL FOLDS AND CHIN AND REPORTED SCARRING. NO CLINIC MEDICAL DIRECTOR NARRATIVE WAS PROVIDED. NO IMAGES WERE PROVIDED. NO TREATMENT PLAN, NOR MEDICAL HISTORY WAS PROVIDED. PROLLENIUM HAS REQUESTED SUPPLEMENTAL INFORMATION ON FOUR OCCASIONS. PROLLENIUM PLANS TO FOLLOW UP WITH SUPPLEMENTAL REQUESTS FOR THE RELEVANT INFORMATION WITH WHICH OUR INVESTIGATION CAN PROCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 18766491 ↗
• InjuryDec 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION/REPORT PROVIDED BY A PATIENT THROUGH ANSWER CONNECT AND LATER BY THE CLINIC, SHE WAS INJECTED WITH A 1.2 ML REVANESSE VERSA+ (WITH LIDOCAINE) IN LIPS. TOPICAL LIDOCAINE 23% TERACAINE 7% WAS APPLIED BEFORE THE INJECTION. 8 HOURS LATER, THE PATIENT CLAIMED THAT SHE GOT LUMPS IN HER LIPS AND SENT SOME IMAGES. THE PATIENT WOULD NOT COME BACK FOR A FOLLOW-UP APPOINTMENT. THE PATIENT ALSO COMMENTED THAT SHE HAD A LUMP IN HER LIP FROM PREVIOUS INJECTION. THE PATIENT STATED THAT SHE HAS GONE TO ANOTHER INJECTOR TO HAVE HYALURONIDASE INJECTED. SHE HAS HAD ONE SESSION OF HYLENEX INJECTED AND FEELS MOST OF THE LUMPS ARE GONE AFTER THIS ONE TREATMENT. THE BATCH RECORD, QC TEST REPORTS (10-JUN-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (20-JUN-2022) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22F077 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. AS PER THE INFORMATION PROVIDED, PROLLENIUM CONSIDERS THE REPORTED AE AS A PENDING ASSESSMENT WITH NO AE DUE TO THE PRODUCT. THE INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340939 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT INFORMATION: BASED ON THE INITIAL INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML PN40083, LOT NUMBER 22L122 ON (B)(6) 2023 WITH 1.0ML OF VERSA ON THE LIPS. THE PATIENT STARTED TO EXPERIENCE UNILATERAL LIP SWELLING, 15 DAYS POST INJECTION. PRIOR TO TREATMENT BLT CREAM WAS USED. THE CLINIC INFORMED THE MANUFACTURER, THAT THE PATIENT WAS GIVEN DOXYCYCLENE 100MG BID FOR A WEEK AND THE SWELLING HAD NOT RESOLVED, SO THE PATIENT WAS BROUGHT BACK TO THE CLINIC WAS GIVEN A VIAL OF HYLENEX TO DISSOLVE THE FILLER. FOLLOW UP COMMUNICATIONS WITH CLINIC: FOLLOWING RECEIPT OF INITIAL REPORT, MANUFACTURER HAS REACHED OUT TO THE CLINIC FOR ADDITION INFORMATION PERTAINING TO THE REPORTED ADVERSE INCIDENT. THIS INFORMATION IS REQUIRED FOR PROLLENIUM'S MEDICAL DIRECTOR TO MAKE A SUITABLE MEDICAL ASSESSMENT OF THE CASE PRESENTED.

  Patient problems: Swelling/ Edema

  MAUDE report 18012126 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD IMMEDIATE SWELLING THAT PROGRESSIVELY GOT WORSE WITHIN HOURS TO THE POINT OF VASCULAR COMPRESSION. NO PAIN PER PATIENT. PATIENT DIRECTED TO THE EMERGENCY ROOM FOR IM OR IV STEROID INJECTION. MEDROL DOSE PACK, BENADRYL AND ZYRTEC PRESCRIBED BY APRN.

  Patient problems: Angioedema

  MAUDE report 17967045 ↗
• InjurySep 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNREPORTED DATE IN (B)(6) 2023 A PATIENT RECEIVED REVANESSE VERSA + INJECTED INTO THEIR TEMPLE REGION. AFTER GOING TO THE GYM POST TREATMENT, THE PATIENT REPORTED AN ERYTHEMATOUS RASH ON ONE TEMPLE. THE INJECTOR REPORTED IT AS LOOKING LIKE "CONTACT DERMATITIS". NO FURTHER HISTORY WAS REPORTED. THERE IS NO HISTORY OF DISINFECTANT OR TOPICAL ANESTHETICS USED. THERE WAS NO PAST MEDICAL HISTORY OR HISTORY OF THE RASH TREATMENT OR OUTCOME. HISTORY OF LUPUS. HASN'T HAD ANY ASSOCIATED SYMPTOMS OF LUPUS FOR OVER 20 YEARS. IN SHORT 22/30 OF THE DIRECT QUESTIONS ON THE INTAKE FORM WERE LEFT UNANSWERED. RASHES POST PROCEDURE ALWAYS HAVE A MULTI FACTORIAL DIFFERENTIAL DIAGNOSIS. UNFORTUNATELY, IN THIS CASE THERE IS NOT ENOUGH INFORMATION TO PROVIDE AN INFORMED CLINICAL OPINION. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17801413 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PATIENT RECEIVED REVANESSE VERSA+ INTO HER MALAR REGIONS. COMPOUNDED HIGH DOSE TOPICAL BLT 30/15/10% ANESTHETIC WAS APPLIED TO THE AREA BEFORE INJECTION. IMMEDIATELY UPON INJECTION, ONLY ON THE LEFT SIDE, THE PATIENT HAD A "SHELF LIKE APPEARANCE" IN THE SUPRA MALAR REGION. THERE WAS NO DISCOLOURATION, NO LUMPS OR NODULES, NO PAIN, NO INFLAMMATION, OR ANY SIGN OF AN ADVERSE EVENT. THE PHOTO PROVIDED SHOWS A SMOOTH LINEAR LINE OF SUPERFICIALLY INJECTED PRODUCT. THIS OF COURSE GIVES THE APPEARANCE OF A RIDGE. NO TREATMENT OR TREATMENT PLAN WAS PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE DOES NOT REPRESENT AN ADVERSE EVENT. IT IS AN ISSUE OF SUB OPTIMAL PRODUCT PLACEMENT WHICH CAN BE EASILY CORRECTED. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 17566400 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR, [ (B)(6), NP] A 61 YO FEMALE, WAS INJECTED WITH 1.2 ML REVANESSE VERSA+ (WITH LIDOCAINE) IN LIPS ON (B)(6) 2022. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THERE WAS NO REPORTED PAST MEDICAL HISTORY. IN (B)(6) 2023, THE PATIENT FELT SEVERAL SMALL LUMPS (ABOUT 10) IN HER LIPS WITH NO PAIN OF INFLAMMATION. SHE WAS SEEN BY HER PCP AND A DERMATOLOGIST BEFORE SHE CONTACTED THE INJECTOR. THE PATIENT WAS PUT ON AN "ANTIBIOTIC" (ABX) AND REPORTED A NOTICEABLE (40%) IMPROVEMENT. THE PATIENT DECLINED AN OFFER TO DISSOLVE THE PRODUCT. THE BATCH RECORD, QC TEST REPORTS (29-JUN-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (08-JUL-2022) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22F183 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A

  Patient problems: Nodule

  MAUDE report 17559673 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PATIENT WAS INJECTED WITH 0.4 ML OF LOT 22L122, REVANESSE VERSA+ HA FILLER INTO THEIR UNDEREYE AREA. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED THE CLINIC FOUR TIMES VIA EMAIL AND PHONE (11-MAY-2023 18-MAY-2023, 24-MAY-2023, 12-JUN-2023) TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. THE CLINIC DID NOT RESPOND. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 17113338 ↗
• InjuryJun 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT'S ACCOUNT: "BACK ON (B)(6) ( (B)(6)TO BE EXACT) I WAS A MODEL FOR THE CLINIC. THE NEXT DAY AND THAT NIGHT I HAD A HORRIBLE REACTION AND I REACHED OUT TO THEM LATER ON, I RECEIVED A PHONE CALL FROM A PERSON IN CLINIC WHO HAD ME GO TO A WALK-IN CLINIC BECAUSE THEY THINK IT WAS JUST ALLERGIES, WHICH IT WASN'T). I HAD TO PAY FOR A VISIT TO THAT CLINIC, WHO PRESCRIBED ME THE BENADRYL AND PREDNISONE THAT DIDN'T REALLY HELP). AFTER GOING BACK AND FORTH, AND A REVIEW ON BBB, THE CLINIC HAD ME REACH OUT TO SOMEONE THAT WOULD DISSOLVE THE FILLERS. ON THE DAY BEFORE I CAME DOWN WITH COVID-LIKE SYMPTOMS SO I CANCELED MY APPOINTMENT, DOING THE RIGHT THING. WHEN I'D ATTEMPTED TO RESCHEDULE AND SAID COVID, A WOMAN THERE FREAKED OUT. THE CLINIC WOULD NOT MAKE A NEW APPOINTMENT, USING THE REASON FOR POSSIBLE COVID WHICH WAS NEGATIVE. I WAS TOLD THAT IF I TOOK DOWN MY BBB REVIEW PERHAPS SHE COULD FIND ANOTHER DOCTOR, WHICH SHE DID. HOWEVER, THAT DOCTOR IS 3 HOURS AWAY. LAST MONTH I SAW A DOCTOR, WHO SUPPOSEDLY DISSOLVED THE FILLERS BUT IT DID NOT WORK. I'VE TRIED REACHING OUT TO THE CLINIC BUT SHE HAS NOT RESPONDED. I ASKED WHAT WAS USED ON MY FACE AND THAT'S WHEN THEY TOLD ME IT WAS REVANES

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17097294 ↗