Revanesse Lips+ with Lidocaine 1.2 mL 40149Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10669808003032), received between Jul 27, 2021 and Sep 21, 2026 — classified as 71 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 reports).

1 other recall cover devices cleared under the same FDA submission (P160042); they may or may not involve this specific model.

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 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A 38-year-old female received 0.3 mL of Revanesse Lips+ (Lot: 25L069) in the upper lip on (b)(6) 2026. Within approximately 5 minutes of injection, localized swelling of the upper lip was observed, and the injector discontinued treatment. Ice was applied and cold compresses were offered. No other medications were administered. The patient had previously received lip filler treatment at another clinic several months earlier. , reportedly RHA2. No autoimmune condition was reported. Topical anesthetic SKNV 23/7% was used. Photographs obtained on (b)(6) 2026 demonstrated localized upper-lip fullness and mild asymmetry without evidence of tissue necrosis or vascular compromise. The event was assessed as localized swelling/edema following treatment and classified as a non-serious adverse event.

  Patient problems: Swelling/ Edema

  MAUDE report 50843103 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50142396 ↗
• InjuryMay 5, 2026Use of Device Problem

  BASED ON THE INFORMATION RECEIVED FROM THE CLINIC, A 49-YEAR-OLD FEMALE PATIENT UNDERWENT FACIAL FILLER TREATMENT WITH REVANESSE LIPS+ 1.2 ML, LOT NUMBER 24D112, ON (B)(6) 2026. THE PATIENT WAS INJECTED 2 SYRINGES OF REVANESSE LIPS+ IN THE MARIONETTE LINES, SMILE LINES AND CHEEKS. THE CLINIC'S INJECTOR REPORTS THAT RIGHT MARIONETTE WAS INJECTED SUPERFICIALLY WITH NEEDLE AND WITH A 22G 2" DERMSCULPT CANNULA. A TINY BRUISE POPPED UP RIGHT AWAY ON THE RIGHT SIDE WITH THE LAST SUPERFICIAL INJECTION. THE CLINIC REPORTS THAT NEXT DAY (B)(6) 2026, THE BRUISE WENT FROM A PENCIL ERASER SIZE TO A HALF DEEP PURPLE AND SLIGHT DUSKY AREA THAT HAD VERY SLOW CAPILLARY REFILL AND PAIN 5/10. ADDITIONAL CLARIFICATION RECEIVED FROM THE CLINIC (INJECTOR) ON 24 APR 2024: THE ACTUAL CHIN WAS NOT INJECTED; TREATMENT IN THIS REGION WAS LIMITED TO THE BILATERAL PRE-JOWL SULCUS AREAS. THE INJECTOR REPORTED TO MANUFACTURER THAT, SHE INITIATED A TREATMENT PROTOCOL. FIRSTLY WITH 1 VIAL OF HYLENEX GOING IN SUPERFICIALLY AND FLOODING THE AREA, FOLLOWED BY MASSAGE AND HEAT APPLICATION. THE PATIENT STILL REPORTED A PAIN SCORE OF 3/10 BUT WITH STILL SLUGGISH CAPILLARY REFILL. 20 MINUTES HAD ELAPSED AND 1 ADDITIONAL

  Patient problems: Ecchymosis; Obstruction/Occlusion; Pain

  MAUDE report 25087267 ↗
• InjuryApr 18, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  ON THURSDAY, (B)(6) 2026, A FEMALE PATIENT CONTACTED ANSWERCONNECT TO REPORT AN ADVERSE EVENT. ACCORDING TO THE PATIENT, SHE RECEIVED INJECTIONS OF REVANESSE® LIPS+ IN HER LIPS. SHE REPORTED ASYMMETRY OF THE LIPS, NOTING THAT THE RIGHT SIDE APPEARED FULLER THAN THE LEFT SIDE FOLLOWING THE TREATMENT. THE PATIENT EXPRESSED CONCERN REGARDING THIS OUTCOME AND REQUESTED TO SPEAK WITH A CONTACT PERSON FROM PROLLENIUM TO OBTAIN ASSISTANCE IN RESOLVING THE ISSUE. THE PATIENT DECLINED TO DISCLOSE THE NAME OF THE CLINIC OR HEALTHCARE PROVIDER WHERE THE INJECTION WAS ADMINISTERED. NO FURTHER DETAILS WERE AVAILABLE REGARDING THE PRODUCT, INCLUDING LOT NUMBER, OR REGARDING THE PATIENT'S DEMOGRAPHIC OR MEDICAL BACKGROUND (E.G., AGE, MEDICAL HISTORY). ADDITIONALLY, NO INFORMATION WAS PROVIDED ON THE INJECTOR AND TREATMENT PLAN, INCLUDING DOSAGE, INJECTION TECHNIQUE, OR PRE OR POST TREATMENT CARE. FOLLOWING RECEIPT OF THE REPORT, THE PROLLENIUM MEDICAL AFFAIRS TEAM ATTEMPTED TO CONTACT THE PATIENT MULTIPLE TIMES (B)(6) 2026, USING THE PHONE NUMBER SHE PROVIDED IN ORDER TO OBTAIN ADDITIONAL. HOWEVER, THE PATIENT DID NOT ANSWER THE PHONE. DUE TO THE LIMITED INFORMATION AVAILABLE, PROLLENIUM WAS UNAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24920939 ↗
• InjuryApr 2, 2026Insufficient Device Problem Information

  BASED ON THE INFORMATION RECEIVED FROM THE CLINIC, THE PATIENT, FEMALE, AGE NOT CONFIRMED WAS INJECTED WITH REVANESSE LIPS,1.2ML (LOT NUMBER WAS NOT CONFIRMED) IN THE LIPS AND EXPERIENCED IMMEDIATE SWELLING, SWELLING WAS OBSERVED TO BE PERSISTENT AND NOT REDUCING DOWN. THE CLINIC ALSO REPORTED THAT A SIMILAR REACTION HAD OCCURRED FOLLOWING A PREVIOUS TREATMENT, WHERE THE SAME PATIENT EXPERIENCED LIP SWELLING EACH MORNING THAT RESOLVED GRADUALLY THROUGHOUT THE DAY AND PERSISTED FOR SEVERAL MONTHS. THIS REACTION DID NOT OCCUR WHEN THE PATIENT WAS PREVIOUSLY TREATED WITH RHA REDENSITY. PROLLENIUM HAS REACHED OUT TO THE CLINIC MULTIPLE TIME TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION; HOWEVER NO RESPONSE WAS PROVIDED. ADVERSE EVENT CLINICAL NARRATIVE: A FEMALE PATIENT OF UNSPECIFIED AGE UNDERWENT LIP AUGMENTATION WITH REVANESSE LIPS. THE EXACT TREATMENT DATE, INJECTION TECHNIQUE, AND VOLUME ADMINISTERED WERE NOT PROVIDED. IMMEDIATELY FOLLOWING TREATMENT, THE PATIENT DEVELOPED SIGNIFICANT LIP SWELLING THAT DID NOT RESOLVE AS EXPECTED IN THE ACUTE POST-PROCEDURAL PERIOD. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED A SIMILAR REACTION FOLLOWING A PREVIOUS DER

  Patient problems: Swelling/ Edema

  MAUDE report 24771833 ↗
• InjuryDec 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON TUESDAY, (B)(6) 2025, A FEMALE PATIENT CONTACTED PROLLENIUM CUSTOMER SERVICE TO REPORT AN ADVERSE EVENT. SHE STATED THAT SHE HAD BEEN TREATED WITH REVANESSE LIPS AND EXPERIENCED AN ALLERGIC-TYPE REACTION, INCLUDING TINGLING AND A SENSATION OF HEAT/BURNING ON HER FACE. THE PROLLENIUM MEDICAL AFFAIRS TEAM CONTACTED THE CLINIC AND REQUESTED ADDITIONAL INFORMATION, WHICH WAS SUBSEQUENTLY PROVIDED. ACCORDING TO THE CLINIC, ON (B)(6) 2025, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ AS FOLLOWS: 0.5 ML INJECTED INTO THE LIPS 0.5 ML** INJECTED AROUND THE MOUTH. FOR PATIENT COMFORT, TOPICAL LIDOCAINE NUMBING CREAM WAS APPLIED TO THE LIPS AND PERIORAL AREA. PRIOR TO LIDOCAINE APPLICATION, THE AREA WAS PREPPED USING HIBICLENS AND AN ALCOHOL PAD. AS THE PATIENT'S REQUEST, ACNE SCARS AROUND THE MOUTH WERE ALSO TREATED. FOR THIS PURPOSE: 0.2 ML OF FILLER WAS HYPER-DILUTED WITH 0.9% SODIUM CHLORIDE AT A 1:1 RATIO. THE PRODUCT WAS INJECTED SUPERFICIALLY USING A 31-GAUGE NEEDLE PROVIDED IN THE PACKAGE. ADDITIONAL COMFORT MEASURES INCLUDED TOPICAL LIDOCAINE CREAM AND INTERMITTENT ICE PACK APPLICATION. THE AREA WAS FURTHER PREPPED WITH HIBICLENS AND AN ACETONE/ETHANOL SOLUTION TO ALLOW FOR ADEQU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881660 ↗
• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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).

  Patient problems: Nodule

  MAUDE report 23854612 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THEY DID A HALF SYRINGE OF JUVEDERM VOLBELLA ON LIPS ON (B)(6) 2024. ALSO HAD DONE A HALF SYRINGE OF VOLBELLA PRIOR TO THAT IN (B)(6) 2023. NO CONCERNS OR MIGRATION WITH EITHER OF THOSE SYRINGES. THEN ON (B)(6) THEY DID 1 ML OF LIPS. ON THE WAY HOME THE PATIENT TEXTED ABOUT "SWELLING" ABOVE THE LIP. SHE CAME BACK 2 WEEKS LATER AND THE MIGRATION WAS STILL PRESENT. 1 CC OF HYLENEX WAS DISSOLVED AND IT INSTANTLY STARTED CHANGING.3 DAYS LATER SHE CAME BACK AND THEY DID ANOTHER 1 CC OF HYLENEX ALONG THE BORDER."

  Patient problems: Swelling/ Edema

  MAUDE report 22761041 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INJECTED 12 DAYS AGO WITH RADIESSE AND REVANESSE LIPS+ AND RHA. 2 AND REDENSITY. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. 7 DAYS POST INFECTION DEVELOPED A RASH, RASH IS MORE PROMINENT IN THE AREAS WHERE THE LIPS+ WAS INJECTED.

  Patient problems: Rash

  MAUDE report 22309240 ↗
• InjuryMay 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT INFORMATION: THE PATIENT IS A 40-YEAR-OLD FEMALE WITH HSV TYPE I WITH LAST OUTBREAK 1 YEAR AGO, NO HISTORY OF INJECTIONS OR ALLERGIES. ALSO DOES NOT HAVE AUTO IMMUNE CONDITIONS. ADVERSE EVENT INFORMATION: THE CLINIC REPORTED ON (B)(6) 2025 THAT PATIENT WHO WAS INJECTED ON (B)(6) 2025 WITH 4 ML OF REVANESSE LIPS+ WITH LIDOCAINE SHOWED ANGIOEDEMA 5-10 MINUTES POST STARTING INJECTION. HOWEVER, THE CLINIC MANAGER REPORTED TO PROLLENIUM MEDICAL THAT THE PATIENT IS DOING FINE NOW. FOLLOW-UP COMMUNICATIONS WITH CLINIC: AFTER RECEIVING THE REPORT ON 16 APR 2025 BY PROLLENIUM, THEY REACHED OUT TO THE CLINIC TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION. RESULTS OF MEDICAL ASSESSMENT: ON (B)(6) 2025 A PATIENT RECEIVED LESS THAN 0.4 CC OF REVANESSE LIPS INTO HER UPPER LIP. PRIOR TO INJECTION THE INJECTING RN APPLIED COMPOUNDED HIGH CONCENTRATION TOPICAL ANESTHETIC BLT (BENZOCAINE, LIDOCAINE, TETRACAINE) TO THE PATIENT'S UPPER AND POWER LIPS. WITHIN 5 MIN OF INJECTING THE UPPER LIP THE PATIENTS BOTH LIPS SWELLED IN AN ALLERGIC NATURE. THE PATIENT WAS GIVEN ONE BENADRYL 50 MG TABLET AND THE SWELLING SUBSIDED. THE SMALL AMOUNT OF HA WAS NOT DISSOLVED. THE SWELLING DID NOT

  Patient problems: Administration Site Swelling

  MAUDE report 22006372 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS THAT PATIENT WAS INJECTED ON (B)(6) 2024 WITH REVANESSE LIPS+ WITH LIDOCAINE ON (B)(6) 2024 IN 0.5 ML CUPID'S BOW, RED VERMILLION TUBERCLE, UPPER AND LOWER LIPS. THE INJECTOR REPORTS THAT SHE OBSERVED ON (B)(6) 2024 THE PATIENT SHOWS TWO SMALL IMPROVING NODULES ARE PRESENT AT THE CORNERS OF THE MOUTH AND TWO ON THE UPPER LIP, CONTINUING TO DECREASE IN SIZE. THE NODULES AT THE MOUTH CORNERS ARE SEMI-HARD AND TENDER, WITH NO ERYTHEMA, SIGNS OF INFECTION, OR BIOFILM. NO FEVER IS PRESENT. MILD SWELLING IS NOTED, CONSISTENT WITH DELAYED-ONSET NODULES. THE PATIENT HAS COMPLETED THE SECOND COURSE OF PREDNISONE 60 MG TAPER AND A PROPHYLACTIC COURSE OF CIPROFLOXACIN 500 MG. OVER THE COURSE OF 9 VISITS FROM (B)(6) 2024 TO (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT THAT INCLUDED INTRALESIONAL HYLENEX AND KENALOG-40 INJECTIONS, ORAL STEROID COURSES, AND ULTRASOUND IMAGING. PROLLENIUM HAS REACHED OUT TO THE INJECTOR/CLINIC MULTIPLE TIME TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION HOWEVER NO RESPONSE WAS PROVIDED.

  Patient problems: Nodule

  MAUDE report 21911776 ↗
• InjuryMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A 21-YO FEMALE PATIENT REPORTED RECEIVING AN INJECTION DURING AN EVENT HOSTED BY THIRD COAST AESTHETICS (B)(6) ON (B)(6) 2025, IN (B)(6). THE INJECTOR, AN APRN AND APNP FROM MERMAID MED SPA (B)(6), ADMINISTERED 1.2 ML OF REVANESSE LIPS+ INTO HER LIPS. THIS WAS THE PATIENT'S FIRST EXPERIENCE WITH A FILLER INJECTION. NO MEDICAL HISTORY WAS DISCLOSED TO THE INJECTOR AT THE TIME OF THE PROCEDURE. IMMEDIATELY AFTER THE INJECTION, THE PATIENT EXPERIENCED BRUISING AND SWELLING IN HER LIPS, WHICH LASTED ABOUT A WEEK. TWO WEEKS LATER, AFTER SEEING NO CHANGE IN HER LIPS' CONDITION, THE PATIENT SOUGHT A SECOND OPINION FROM A LOCAL INJECTOR WHO ALSO USES VERSA PRODUCTS. THIS INJECTOR CONFIRMED THERE WAS NO FILLER IN HER LIPS. WHEN THE PATIENT REACHED OUT TO THE ORIGINAL INJECTOR, THEY RESPONDED DEFENSIVELY AND DENIED THE CLAIM. IN SUMMARY, WHILE THE PATIENT DOES NOT WISH TO FILE A FORMAL COMPLAINT REGARDING THE ADVERSE EVENT, SHE IS DISSATISFIED WITH HAVING PAID FOR THE TREATMENT AND NOT SEEING ANY FILLER RESULTS. PROLLENIUM REQUESTED ADDITIONAL INFORMATION FROM THE TREATMENT CLINIC. THE INJECTOR PROVIDED THE AVAILABLE DATA, DENIED RECEIVING ANY COMPLAINT FROM THE PATIENT, AND REFERRED TO THEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566667 ↗
• InjuryFeb 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT: PATIENT WAS INJECTED BY TRAINEE (B)(6) , PRE-JOWL SULCUS AREA, BOLUS DEEP INJECTION. ABOUT 15 MINUTES AFTER INJECTION TO THE AREA, THE AREA BEGAN TO BECOME DUSKY COMPARED TO REMAINDER OF THE AREA WHICH WAS BRUISED. PATIENT HAD A MODERATE AMOUNT OF TENDERNESS OF THAT AREA COMPARED TO THE REST OF THE CHIN AND CONTRALATERAL SIDE OF PRE-JOWL SULCUS. THIS AREA OF INJECTION HAD A SLUGGISH AND DELAYED CAPILLARY REFILL COMPARED TO THE SURROUNDING AREA. HYLENEX 2 VIALS WERE INITIALLY INJECTED INTO THE AREA. A WARM COMPRESS WAS APPLIED, AND THE AREA WAS MASSAGED. THE PATIENT WAS GIVEN AN ASA BY OWNER/INJECTOR PA-C. THE PATIENT APPLIED THE WARM COMPRESS FOR 15 MINUTES AND THE PATIENT'S SYMPTOMS WERE IMPROVED. THE CAPILLARY REFILL IMPROVED SLIGHTLY. THE PATIENT'S DISCOMFORT IMPROVED SLIGHTLY, AND THE DUSKY COLOR IMPROVED TO A PINKISH/PURPLE DISCOLORATION. OWNER/INJECTOR WAS CONCERNED ABOUT POSSIBLE OCCLUSION ALTHOUGH APPEARED TO BE MORE OF A VASOSPASM. SHE ADMINISTERED ANOTHER ROUND OF HYLENEX. THE AREA WAS MASSAGED, AND WARM COMPRESS WAS APPLIED. PATIENT MONITORED FOR ANOTHER 15 MINUTES. CAPILLARY REFILL IMPROVED, BUT JENNIE WAS CONCERNED AND ADMINISTERED ANOTHER VIAL OF HYLENEX. HEAT

  Patient problems: Skin Discoloration

  MAUDE report 21493099 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT RECEIVED INJECTION WITH REVANESSE LIPS+. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THE SYMPTOMS OCCURRED THREE WEEKS POST INJECTION. SWELLING IN LOWER LIP AT 3.5 WEEKS, STILL THERE BY (B)(6) AND WAS GONE WHEN SHE CAME BACK TO SEE THE CLINIC. THE PATIENT FEELS SHE CANNOT SEE THE FILLER AT ALL NOW. SHE WORKS FOR A DERM WHO TOLD HER TO TAKE AN ANTIHISTAMINE WHICH SHE DID, AND SWELLING WENT AWAY.

  Patient problems: Swelling/ Edema

  MAUDE report 21450971 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE INJECTOR, 0.5 ML OF REVANESSE LIPS+ WAS INJECTED INTO THE LIPS OF A 22-YEAR-OLD FEMALE PATIENT ON (B)(6)2025. THE PATIENT DEVELOPED AN IMMEDIATE BRUISE FOLLOWING THE LIP INJECTION. THE PATIENT TOOK ASPIRIN 48 HOUR AGO, AND THE BRUISING DID NOT EXTEND TO HER FACE. PROLLENIUM HAS REQUESTED MORE INFORMATION FROM THE CLINIC ASSOCIATED WITH THE INJECTION (E.G. INJECTION PLAN,) AND PATIENT (MEDICAL HISTORY) AND IMAGE BEFORE THE INJECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED DESPITE OF SEVERAL REQUESTS BY PROLLENIUM THROUGH EMAIL [03-FEB-2025, 28-JAN-2025, 27-JAN-2025,23-JAN-2025,20-JAN-2025,20-JAN-2025,16-JAN-2025,14-JAN-2025,13-JAN-2025,09-JAN-2025]. THE LOT NUMBER 24K167 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. 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 LIMITED INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM'S MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE

  Patient problems: Easy Bruising

  MAUDE report 21339216 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNSPECIFIED DATE A NP PROVIDER INJECTED REVANESSE LIPS+ INTO A PATIENTS LIPS. THERE IS NO ASSOCIATED PATIENT DATA, HISTORY OR PHOTOS PROVIDED. THERE WERE NO REPORTED ADVERSE EVENTS. THE ONLY INFORMATION THE INJECTING NP PROVIDED CAME IN THE FORM OF A QUESTION. " I JUST WANTED TO ASK, HAVE YOU HEARD OF A PATIENT GETTING TRANSIENT LIP SWELLING, LASTING ONLY A COUPLE OF HOURS, AFTER DRINKING THE NIGHT BEFORE?" MY CLINICAL OPINION IS THAT THERE IS NO INFORMATION PROVIDED IN THIS CASE TO INDICATE AN ADVERSE EVENT TO HA FILLER. TRANSIENT LIP SWELLING THE MORNING AFTER DRINKING (ALCOHOL OR FLUIDS) IS A USUAL CONSEQUENCE OF EXCESS DRINKING THE NIGHT BEFORE. INTERNAL REPORT NUMBER: (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 21072717 ↗
• InjuryDec 12, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024 A PATIENT RECEIVED 0.4 CC OF REVANESSE LIPS + INTO HER LIPS. PRIOR TO THE TREATMENT THE PATIENT RECEIVED "IV VITAMINS" AND HAD "A TOPICAL NUMBING OINTMENT FROM EMPOWER PHARMACY " APPLIED TO THEIR LIPS, PRIOR TO INJECTION. THERE WERE NO DOCUMENTED CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THREE DAYS LATER THE PATIENT NOTICED A "SMALL OVAL SHAPED FORMATION ON THE LEFT UPPER LIP" AND WAS INSTRUCTED TO GENTLY MASSAGE THE AREA. THERE WAS NO ERYTHEMA, INFLAMMATION OR NODULES. THE PHOTOS PROVIDED ALL CLEARLY SHOWN AN AREA OF SUPERFICIAL PRODUCT DEPOSITION ON THE LEFT UPPER LIP. EVENTUALLY ON (B)(6) 2024 THE SUPERFICIALLY INJECTED PRODUCT WAS DISSOLVED WITH HYALURONIDASE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 20917905 ↗
• InjuryDec 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PROLLENIUM RECEIVED AN ANSWERCONNECT REPORT ON THURSDAY, (B)(6) 2024. A PATIENT (PT) REPORTED EXPERIENCING HARD AND LUMPY LIPS FOLLOWING AN INJECTION. THE PATIENT INDICATED THAT THE TREATMENT WAS PERFORMED AT THE "(B)(6)" CLINIC, AND SHE WAS EXPERIENCING SYMPTOMS OF AN ASYMMETRICAL FACE WITH LUMPY LIPS. THE PROLLENIUM REACHED OUT TO THE CLINIC FOR MORE DETAILS. AS PER THE CLINIC, ON (B)(6) 2024, THE PATIENT RECEIVED AN INJECTION OF LESS THAN 1.2 ML OF THE REVANESSE LIPS+ INTO HER LIPS. THERE WERE NO COMPLAINTS OR ADVERSE EVENTS DURING OR IMMEDIATELY AFTER THE INJECTION. TWO DAYS LATER, THE PATIENT INFORMED THE CLINIC THAT HER LIPS FELT UNEVEN AND SWOLLEN. THE CLINIC ASSURED HER THAT SWELLING WAS NORMAL AND ADVISED HER TO WAIT FOR THE FILLER TO SETTLE. THE PATIENT CONTINUED TO CONTACT THE CLINIC IN THE FOLLOWING DAYS, EXPRESSING ONGOING CONCERNS. THE CLINIC SCHEDULED AN APPOINTMENT FOR HER ON (B)(6) 2024. DURING THAT VISIT, THE NURSE ADDED A SMALL AMOUNT OF FILLER AND TOXIN TO ADDRESS MUSCLE ASYMMETRY. BASED ON PICTURES FROM THAT DAY, THERE WAS NO EVIDENCE OF MIGRATION OR ADVERSE REACTIONS, AND THE LIPS APPEARED EVEN AND WELL-DEFINED. THE NURSE EXPLAINED MULTIPLE TIMES THAT ASYMMETR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842833 ↗
• InjuryJul 22, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) 1.2ML,23K091 ON (B)(6) 2024 ON THE LIPS, 1.0ML OF PRODUCT WAS INJECTED. THE PATIENT CAME FOR A FOLLOW UP TWO WEEKS LATER AND COMPLAINED OF HER LIPS FEELING CHAPPED AT THE WET DRY BORDER. THEY ARE TENDER AND IRRITATED AND STILL SLIGHTLY SWOLLEN. THE PATIENT HAS ONLY USED AQUAPHOR ON HER LIPS FOR THE PAST FEW WEEKS. THE PATIENT HAS HAD FILLER PREVIOUSLY, BUT IT'S BEEN ABOUT 1 YEAR AGO.PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT CAN BE FOUND BELOW: THE FOLLOWING IS A CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A RN INJECTED 1.0CC OF REVANESSE LIPS + INTO A PATIENT'S LIPS. THE WERE NO CONCERNS OR ADVERSE EVENTS REPORTED AT THE TIME OF INJECTION. NO PAST MEDICAL HISTORY SUCH AS MEDICATIONS, ALLERGIES OR RECENT INFECTIONS WAS PROVIDED. NO BEFORE OR AFTER PHOTOS WERE PROVIDED. TWO WEEKS LATER THE PATIENT CALLED THE INJECTING RN TO COMPLAIN THAT HER LIPS " FELT DRY AND CHAPPED". THE PATIENT HAD BEEN APPLYING AQUAPHOR OINTMENT TO HER LIPS FOR 2 WEEKS. NO MEDICAL EXAM WAS PERFORMED OR PROVID

  Patient problems: Dry Skin; Swelling/ Edema

  MAUDE report 19795326 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINIC'S ACCOUNT WAS SENT ON 26-APR-2024: "INJECTED .8 IN LIPS, .4 IN CHIN, RADIESSE IN JAW LINE AND CHEEKS. INJECTED HER ON (B)(6). EVERYTHING WAS FINE UNTIL SHE GOT ON THE CRUISE ON THURS (B)(6) AND ON SUNDAY (B)(6) SHE REACHED OUT TO HER INJECTOR AND HER LIPS WERE REALLY SWOLLEN, PAINFUL AND FELT LIKE THERE IS LITTLE BB'S IN THEM. INJECTOR PRESCRIBED A STEROID PACK. TOOK FIRST DOSE YESTERDAY AND SWELLING IS DOWN TODAY BUT STILL BUMPS." HERE'S THE CLINICAL OPINION BY (B)(6) MEDICAL DIRECTOR", ON 31-MAY-2024: "THE FOLLOWING IS A CLINICAL RESPONSE BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A PATIENT RECEIVED REVANESSE LIPS+ INTO THEIR LIPS AND CHIN. PRIOR TO INJECTION HIBICLENS, ALCOHOL, LIDOCAINE, TETRACAINE AND PHENLYEPHRINE WERE ALL APPLIED TO THE LIPS. RADIESSE WAS ALSO INJECTED INTO THE PATIENTS' CHEEKS AND JAW LINE. THERE WERE ADVERSE EVENTS OR CLINICAL CONCERNS AT THE TIME OF INJECTION. THE PATIENT WENT ON A CRUISE ON (B)(6) 2024 AND ON (B)(6) 2024, AFTER BEING IN THE SUN FOR THREE DAYS, REPORTED TO THEIR INJECTOR THAT THEIR LIPS WERE SWOLLEN AND THEY COULD FEELS TINY BUMPS. THE CHIN, CHEEKS AND JAWLINE WERE NOT SWOLLEN. IT WAS LATER DIAGNOSED THAT

  Patient problems: Swelling/ Edema

  MAUDE report 19471291 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT INFORMATION: THE NURSE INJECTOR REPORTS THAT THE PATIENT WAS INJECTED ON THE 15-APR-2024 AT 4PM, WITH 0.6ML OF REVANESSE LIPS+. NUMBING CREAM USED LIDO,10% BENZO 20%, TETRA 10% NUMBED FOR 25 MINS. REVIEWED ALLERGY CHART - NONE PRESENT. LEFT NUMBING ON BOTTOM LIP WHILE INJECTING TOP LIP. BACKED FILLED PRODUCT INTO A 1ML SYRINGE TO .6 ML. USED NEEDLES THAT CAME IN LIPS+ BOX. USED FENCING TECHNIQUE AND INJECTED TOP - 0.4 AND 0.2 IN BOTTOM BODY OF LIP. INJECTOR CHECKED LIPS POST, NO COMPLICATIONS, SLIGHT SWELLING, OFFERED SINGLE USE COLD COMPRESS FOR 5 MINUTES. PATIENT WAS GIVEN POST CARE INSTRUCTIONS AS WELL AS GLYMED HYDRATING LIP BALM. PATIENT WOKE UP 26-APR-2024 AND SENT INJECTOR A TEXT MESSAGE 6:30AM WITH SWELLING PRESENT IN UPPER LIP ONLY, INJECTOR ASSESSED OVER FACETIME AND LIP WAS NOT RED,PROFUSION PRESENT, NO PAIN, NO ITCHING, BUT DID FEEL SINUS PRESSURE. WAS OFFERED PEPCID, ZYRTEC, AND BENADRYL. SWELLING WAS BACK TO NORMAL BY EVENING 26-APR-2024. PATIENT WOKE UP 30-APR-2024 SENT TEXT TO INJECTOR WITH SWELLING PRESENT ON BOTTOM LIP ONLY. PATIENT TOOK PEPCID AND ZYRTEC IN THE AM PRE ASSESSMENT AND MEDICAL DIRECTOR ASSESSED WITH INJECTOR WHEN PATIENT CAME INTO THE

  Patient problems: Swelling/ Edema

  MAUDE report 19449444 ↗
• InjuryMay 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PROLLENIUM RECEIVED THE ADVERSE EVENT REPORT ON 04-APR-2024. DETAILS BELOW : THE INJECTOR INFORMS THE MANUFACTURER THAT SHE HAS HAD 5 PATIENTS THAT HAVE BUMPS ON THE TOP UPPER LIP OCCURRING APPROXIMATELY 1 YEAR AFTER BEING INJECTED. THE PATIENTS AGE RANGE WAS FORM 25 YRS TO MID 40S'S. THESE WERE ALL FIRST TIME LIP FILLER PATIENTS. ALL OF THESE PATIENTS WERE INJECTED AROUND THE SAME TIME AND RETURNING LIP FILLER PATIENTS WERE NOT EXPERIENCING THESE REACTIONS. PROLLENIUM HAS COMPLETED MULTIPLE ATTEMPTS TO REQUEST THE INJECTOR FOR DETAILS ON EACH PATIENT TO EVALUATE THE REPORTS ON A CASE-BY-CASE BASIS. NO RESPONSE HAS BEEN PROVIDED SO FAR. PRODUCT NAME AND LOT NUMBER COULD NOT BE CONFIRMED. PROLLENIUM HAS COMPLETED MULTIPLE ATTEMPTS TO REACH OUT THE CLINIC,NO RESPONSE HAS BEEN PROVIDED SO FAR. PROLLENIUM SHALL PROVIDE THE CLINIC WITH A 30 DAY NOTICE LETTER. THE INVESTIGATION COULD NOT BE ADEQUATELY COMPLETED OWING TO THE LACK OF INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19241822 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER THE INJECTOR (AND THE CLINIC MEDICAL DOCTOR), NP, 0.4 ML, TWICE, 2 WEEKS APART OF REVANESSE LIPS +(WITH LIDOCAINE) WAS INJECTED TO THE LIPS OF A FEMALE ON 15-NOV-2023. NO CONCERN OR ADVERSE EVENT WAS REPORTED AT THE TIME OF INJECTION. POST - INJECTION, THE PATIENT STATED HER LIPS WERE QUITE DRY AND HAVE STAYED THAT WAY SINCE HER INJECTIONS IN NOVEMBER OF 2023. SHE JUST INFORMED THE INJECTOR OF THIS ISSUE ON MARCH 28, 2024, SO IT HAS BEEN OCCURRING FOR JUST OVER 4 MONTHS. PROVIDER WOULD LIKE TO KNOW IF THERE IS A POSSIBLE CAUSAL RELATIONSHIP BETWEEN LIP INJECTIONS WITH REVANESSE LIPS AND DRY, PEELING LIPS. ON 09-APR-2024, THE INJECTOR, IN RESPONSE TO THE PMT'S EMAIL (TO REQUEST FURTHER INFORMATION ABOUT AE), SAID THAT SHE WAS ABLE TO SEE THE PATIENT IN PERSON AND ASKED MORE QUESTIONS. TURNS OUT IT WAS ALL FROM DEHYDRATION AND NOT THE FILLER AS SHE ALSO STARTED ON A WEIGHT LOSS PRODUCT. AROUND THE SAME TIME SHE HAD DONE FILLERS AND HAS NOT BEEN DRINKING ENOUGH WATER. THE INJECTOR HAS REQUESTED PMT NOT TO FURTHER INVESTIGATE THE REPORTED AE. THE BATCH RECORD, QC TEST REPORTS (24-AUG-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (01-SEP-2022) WERE ANALYZED AND IT HAS BEEN DET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231952 ↗
• InjuryMar 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON JANUARY 22, 2024 A PATIENT RECEIVED REVANESSE LIPS + INTO THEIR LIPS, NASOLABIAL FOLDS AND LATERAL PERIORAL SMILE LINES (OVER THE MODIOLUS). A DENTAL BLOCK OF 2% LIDOCAINE WITH EPI. WAS PERFORMED PRE PROCEDURE. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. ON JANUARY 26, 2024 THE PATIENT CALLED CONCERNED WITH "SWELLING" AROUND THE RIGHT PERIORAL SMILE LINE INJECTION. THERE WAS NO ERYTHEMA, NO INFLAMMATION, NO PAIN, NO DISCOLOURATION AND NO LUMPS OR NODULES. THERE WERE NO OTHER SWOLLEN AREAS. THE PHOTOS PROVIDED SHOWS AN ISOLATED FULLNESS IN THE AREA OF THE RIGHT PERIORAL INJECTION SITE. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS AN AREA OF PRODUCT THAT WAS INJECTED IN A SUBOPTIMAL PLANE OVER THE MODIOLUS, WHICH IS THE INTERSECTION OF MULTIPLE MUSCLES THAT CONTROL THIS HIGHLY EXPRESSIVE AREA OF THE FACE. THIS MOBILITY CAUSES AN IMPRESSION OF FULLNESS DUE TO THE MUSCLE ACTIVITY. THIS APPEARANCE WILL IMPROVE WITH TIME AS THE PRODUCT INTEGRATES INTO THE TISSUE. IF WAITING IS NOT AN OPTION THE PRODUCT CAN BE DISSOLVED WITH HYLURONIDASE. I TRUST THIS CLINICAL OPINION WILL B

  Patient problems: Swelling/ Edema

  MAUDE report 18848582 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 A PATIENT RECEIVED 0.75CC OF REVANESSE LIPS+ INTO THEIR LIPS. PRIOR TO INJECTION THE PATIENT RECEIVED CHLORHEXADINE MOUTH RINSE AND COMPOUNDED LIDOCAINE 23% + TETRACAINE 7% TOPICAL ANESTHETIC APPLIED TO THEIR LIPS AND THEREFORE INTO THEIR MOUTH. THE PATIENT ALSO HAD A LIP INJECTION WITH THE SAME PRODUCT IN (B)(6) 2023 WITH NO ISSUES OR ADVERSE EVENTS. DURING THE INJECTION THE INJECTOR FELT THAT THE LIPS "BLANCHED" VERY EASILY AND APPEARED "MORE IRRITATED". THESE CONCERNS RESOLVED BY THE END OF THE INJECTION AND THERE WAS NO CONCERNS OR ADVERSE EVENTS AT THE END OF APPOINTMENT. THE INJECTOR WAS CONFIDENT THAT THERE WAS NO "VASCULAR OCCLUSION". AT A FOLLOW UP VISIT 4 WEEKS LATER IT WAS NOTED THAT THE PATIENTS LIPS STILL "LOOKED SWOLLEN". THERE WAS NOT PAIN, NO ANGIOEDEMA OR SIGNS OF ALLERGIC REACTION, NO NODULES AND NO INFLAMMATION. THE AFTER PHOTOS SHOW A LOWER LIP THAT IS SIMILAR IN SIZE AND SHAPE TO THE PRE PHOTO. THE UPPER LIP IS FILLED TO A SIZE LARGER THAN THE LOWER LIP, WHICH IS NOT A NATURAL OR PRE FILLER STATE. THE VERMILLION BORDER IS NOT SWOLLEN OR DISTORTED AND THE LIP CREASES / WRINKLES ARE STILL PRESENT. PRODUCT CAN BE SEEN THRU THE EPITHELIUM OF THE UPPE

  Patient problems: Swelling/ Edema

  MAUDE report 18768853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160042. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2020 · Nov 15, 2018 · Terminated
  Revanesse Versa, PN40081