RHA® 2 RHA® 2 (1mL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07640173230021), received between Dec 23, 2021 and May 14, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF USA IN UNITED KINGDOM. ON 14-APR-2025, THE UK SUBSIDIARY NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS INJECTED: ON (B)(6) 2024 WITH 1 ML OF RHA3 IN THE LIPS (0.3ML) AND IN THE NASOLABIAL FOLDS (0.7 ML) USING RETROTACING AND FANNING TECHNIQUES, A NEEDLE FOR THE LIPS AND A CANNULA FOR THE NLF (CURRENT COMPLAINT). ON (B)(6) 2024 WITH 0.6 ML OF RHA 2 IN THE LIPS (0.4 ML) AND IN THE ORAL COMMISSURES (0.2 ML) USING RETROTACING AND FANNING TECHNIQUES, A NEEDLE FOR THE LIPS AND A CANNULA FOR ORAL COMMISSURES. (RC/2504067). THE PATIENT ALSO RECEIVED INJECTION OF AZZALURE (BOTULINUM TOXIN) IN THE GLABELLA ON (B)(6) 2024. APPROXIMATELY 3 MONTHS AFTER THE LAST INJECTIONS, AROUND ON (B)(6) 2025, THE PATIENT EXPERIENCED AN HYPERSENSITIVITY REACTION ON HER FACE AND WAS HOSPITALIZED FOR 2 DAYS. THIS CASE WAS ASSESSED AS SERIOUS AND REPORTABLE. THE PATIENT WAS PRESCRIBED THE FOLLOWING TREATMENTS DURING HER HOSPITALIZATION: ANTIBIOTIC TREATMENT (FLUCLOXACILLIN), PREDNISOLONE 30 MG REDUCING BY 5 MG EVERY 5 WEEK UNTIL 6 WEEKS, PPI OMEPRAZOLE 20 MG. A LOCAL MEDICAL EXPERT WAS CONTACTED FOR GUIDANCE. HE RECOMMENDED HY

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22016368 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF USA IN UNITED KINGDOM. ON 14-APR-2025 THE UK SUBSIDIARY NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS INJECTED: - ON (B)(6) 2024 WITH 1 ML OF RHA3 IN THE LIPS (0.3ML) AND IN THE NASO LABIAL FOLDS (0.7 ML) USING RETROTRACING AND FANNING TECHNIQUES, AR NEEDLE FOR THE LIPS AND A CANNULA FOR THE NLF ((B)(4)). - ON (B)(6) 2024 WITH 0.6 ML OF RHA 2 IN THE LIPS (0.4 ML) AND IN THE ORAL COMMISSURES (0.2 ML) USING RETROTRACING AND FANNING TECHNIQUES, A NEEDLE FOR THE LIPS AND A CANNULA FOR THE ORAL COMMISSURES. (CURRENT COMPLAINT). THE PATIENT ALSO RECEIVED INJECTION OF AZZALURE (BOTULINUM TOXIN) IN THE GLABELLA ON (B)(6) 2024. APPROXIMATELY 3 MONTHS AFTER THE LAST INJECTIONS, AROUND THE (B)(6) 2025, THE PATIENT EXPERIENCED AN HYPERSENSITIVITY REACTION AND WAS HOSPITALIZED FOR 2 DAYS. THIS CASE WAS ASSESSED AS SERIOUS AND REPORTABLE. THE PATIENT WAS PRESCRIBED THE FOLLOWING TREATMENTS DURING HER HOSPITALIZATION: - ANTIBIOTIC TREATMENT (FLUCLOXACILLIN). - PREDNISOLONE 30 MG REDUCING BY 5 MG EVERY 5 WEEK UNTIL 6 WEEKS. - PPI OMEPRAZOLE20 MG. A LOCAL MEDICAL EXPERT WAS CONTACTED FOR GUIDANCE. THE LATER RECOMM

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22016366 ↗
• InjuryDec 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA IN SPAIN. ON 14-NOV-2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.4 ML OF RHA 2 IN THE TEMPLES USING A 25-GAUGE CANNULA AND THE RETRACTING TECHNIQUE. THE DAY OF THE INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INCREASE IN VOLUME, LOOKING AS A HEMATOMA IN THE LEFT TEMPLE. THE INJECTOR PERFORMED COMPRESSION AND MASSAGE. ONE DAY AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT REPORTED A YELLOW-GREENISH COLOR IN THE LEFT TEMPORAL AREA, SENSITIVITY IN THE AREA, AND SLIGHT PAIN WHEN TOUCHED. ONE DAY LATER, ON (B)(6) 2024, THE PATIENT COMPLAINED ABOUT THE WORSENING OF PAIN AND THE EXPENSION OF THE HEMATOMA ALONG THE ENTIRE IMPLANTATION LINE OF THE AREA. THE INJECTOR PROPOSED A NEW APPOINTMENT, BUT THE PATIENT WAS NOT ABLE TO COME. ON (B)(6) 2024 THE PATIENT EXPERIENCED ALOPECIA PLAQUE/HAIR LOSS UPPER THE LEFT TEMPLE. A LOCAL MEDICAL EXPERT WAS CONTACTED TO MAKE A DIAGNOSIS, AND ACCORDING TO HIM, THE ALOPECIA WAS DUE TO A COMPRESSIVE PHENOMENON, EITHER FROM THE HEMATOMA CAUSED BY THE INJECTION OF FROM THE DERMAL FILLER ITSELF. THEREF

  Patient problems: Foreign Body Embolism

  MAUDE report 20922804 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE USA IN SPAIN. ON 23-JUL-2024, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.5ML OF RHA 2 IN THE LIPS (0.3ML IN THE UPPER LIP AND 0.2ML IN THE LOWER LIP, RETROTRACING TECHNIQUE). WHILE PERFORMING THE LIP AUGMENTATION TREATMENT, THE PATIENT'S LIP BEGAN TO SWELL EXCESSIVELY. AFTER A FEW SECONDS, THE PATIENT BEGAN TO FEEL DIZZY AND LOST CONSCIOUSNESS FOR APPROXIMATELY 2 SECONDS. WHEN SHE REGAINED CONSCIOUSNESS, SHE WAS HYPOTENSIVE (80/60 BP), SWEATY, NAUSEATED, SKIN PALE, AND HAD 5 EPISODES OF VOMITING. THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, AND AFTER LOCAL COLD, HYDRATION, AND REST FOR 60 MINUTES, THE SYMPTOMS RESOLVED. SHE ALSO RECEIVED CORTICOIDS ANTI-INFLAMMATORY TREATMENT. THE INJECTOR CONTACTED THE PATIENT 3 HOURS LATER; SHE REPORTED PRESENTING SWELLING IN HER LIP, BUT WITH IMPROVEMENT OF THE ASSOCIATED SYMPTOMS. AFTER 24 HOURS, THE PATIENT CONTINUED TO HAVE SWELLING AND EDEMA IN THE LIP, BUT OF REDUCED INTENSITY. ADDITIONALLY, MEDICAL ASSISTANCE WAS PROVIDED. THE LOCAL MEDICAL EXPERT THOUGHT THAT IT COULD BE AN ALLERGY TO LIDOCAINE OR ANY

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20025382 ↗
• InjuryAug 8, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURRED OUTSIDE OF THE USA, IN SPAIN. ON 09-JUL-2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON : - 26-MAR-2024 WITH 0.8ML OF RHA 2 IN THE TEAR TROUGHS (CURRENT COMPLAINT) - 10-APR-2024 WITH 0.8ML OF RHA 4 IN THE CHEEKBONES (RC/2407040) - 10-APR-2024 WITH 1.4ML OF TEOSYAL PURESENSE ULTRA DEEP IN THE CHEEKBONES (RC/2407041) ON 25-JUN-2024, THE PATIENT PRESENTED WITH LATE NODULATION IN THE MALAR AREAS, OF MODERATE INTENSITY. THE FOLLOWING DAY, THE PATIENT STARTED AN ANTIBIOTIC TREATMENT (AUGMENTIN) FOR 10 DAYS. ON 03-JUL-2024 THE PATIENT WENT TO THE HOSPITAL INSTEAD OF GOING TO THE INJECTOR'S CLINIC. AN ULTRASOUND WAS PERFORMED: IN THE RIGHT MALAR REGION SEVERAL COLLECTIONS WERE OBSERVED (THE LARGEST MEASURING 4X1.2CM, ONE ADJACENT MEASURING 1X1CM WITH SLIGHT HYPERECHOGENICITY OF THE FAT, SEVERAL SMALLER COLLECTIONS BETWEEN 0.5 AND 0.6CM ALONG THE RIGHT TERRITORY, AND A COLLECTION WITH SIMILAR CHARACTERISTICS AT THE RIGHT PERIOCULAR LEVEL OF 1.9 X 1.2CM). COLLECTIONS WERE ALSO OBSERVED ON THE LEFT SIDE OF THE FACE (MULTIPLE COLLECTIONS OF 3.9X1.4CM IN THE MALAR REGION AND IN THE LEFT

  Patient problems: Skin Infection

  MAUDE report 19938709 ↗
• InjuryJul 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA, IN AUSTRALIA. ON 11-JUL-2024, THE AUSTRALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT.  A PATIENT WAS INJECTED ON (B)(6) 2024 BY A NURSE WITH RHA 2 IN THE NASOLABIAL FOLDS, IN THE ORAL COMMISURES, AND IN THE MARIONETTE LINES. A 25G CANNULA WAS USED TO LAYER THE ACID HYALURONIC IN THE SUBDERMAL AND SUBCUT PLANES.  THE PATIENT HAD A HISTORY OF FILLER INJECTIONS IN THE NASOLABIAL FOLDS AND MARIONETTE LINES, AS WELL AS BOTULINUM TOXIN TREATMENT ON (B)(6) 2023 WITHOUT ANY ISSUE.  IMMEDIATELY AFTER THE INJECTION, THE PATIENT PRESENTED WITH DISCOLOURATION AND LARYNGEAL HYPERSENSITIVITY SYNDROME (LHS) IN THE NASOLABIAL FOLDS (NOSTRIL). THE SAME DAY, THE PRESCRIBING DOCTOR WAS CONTACTED FOR A SECOND OPINION. HE WAS UNSURE IF THERE WAS A VASCULAR OCCLUSION AND WAS ADVISED TO MONITOR THE PATIENT OVER THE NEXT 24 HOURS AND REVIEW IF NEEDED. THE PATIENT DID NOT PRESENT WITH ANY PAIN, AND THE SYMPTOMS SEEMED TO SUBSIDE AFTER 10-15 MINUTES. THEREFORE, THE SYMPTOMS WERE SUSPECTED OF BEING HEMATOMA.  THE NEXT DAY, ON (B)(6) 2024, THE PATIENT CONTACTED THE TREATING NURSE, SENDING A PHOTO OF THE CONCERNED AREA. THE NURSE SUSPECTED A LIVEDO-RETICULAR

  Patient problems: Foreign Body Embolism

  MAUDE report 19817395 ↗
• InjuryMay 23, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 23-APR-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH A TOTAL OF 0.65 ML OF RHA 2 IN THE LIPS. THE INJECTION WAS DONE WITH THE NEEDLE PROVIDED IN THE BOX.  THE MEDICAL HISTORY OF THE PATIENT MENTIONED THAT SHE WAS TAKING AN ANTIDEPRESSANT (ZOLOFT) FOR ANXIETY AND WAS ALLERGIC TO ESTROGEN. THE SAME DAY, AT NIGHT, AFTER THE INJECTION, THE PATIENT CONTACTED THE INJECTOR AND ASKED FOR THE FILLER TO BE DISSOLVED. THE PICTURES PROVIDED BY THE PATIENT SHOWED ONLY EXPECTED SWELLING. THE NEXT AFTERNOON, ON (B)(6) 2024, THE INJECTOR CALLED THE PATIENT ON FACETIME, AND SHE COMPLAINED ABOUT EXTREME PAIN. THE INJECTOR CHECKED THE SKIN AND CAPILARY REFILL, BUT NO BLANCHING OR BRUISING WERE NOTED. THE INJECTOR PRESCRIBED THE FOLLOWING TREATMENT: ANTIHISTAMINE (BENADRYL) AT NIGHT. ICE AND A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (IBUPROFEN) DURING THE DAY. THE NEXT DAY, ON (B)(6) 2024, THE PATIENT CONTACTED THE INJECTOR ONCE AGAIN AND ASKED FOR THE FILLER TO BE DISSOLVED. THE PATIENT ALSO TOLD  THAT SHE SPOKE WITH A FRIEND WHO WAS ALSO AN AESTHETIC INJECTOR AND MENTIONED SHE HAD SOME COMPLICATIONS WITH THE PRODUCTS. HOWEVER, THE PATIENT'S PIC

  Patient problems: Foreign Body Embolism

  MAUDE report 19379414 ↗
• InjuryMay 17, 2024Use of Device Problem; Use of Device Problem

  THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 19-APR-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH TEOSYAL RHA 2 IN THE LIPS (0.25 ML IN THE LOWER LIP AND 0.25 ML IN THE UPPER LIP). THE INJECTION WAS DONE WITH THE VERTICAL TECHNIQUE USING THE NEEDLE PROVIDED IN THE BOX. BEFORE THE INJECTION, THE PATIENT RECEIVED ANESTHETIC CREAM. IMMEDIATELY AFTER THE INJECTION, THE PATIENT EXPERIENCED A STRONG OEDEMA IN THE LIPS. THE SAME DAY, THE INJECTOR PRESCRIBED CORTICOIDS (BENTELAN 4 MG), BUT THE OEDEMA PERSISTED. THEREFORE, WITH THE SUPPORT OF THE LOCAL MEDICAL EXPERT, THE PATIENT WAS TREATED WITH AN INTRAMUSCULAR INJECTION OF CORTISOIDS (BENDELAN) AND ANTIHISTAMINES (TRIMETON). AFTER THE TREATMENT, THE SYMPTOMS IMPROVED.  FROM (B)(6) 2024, THE PATIENT STARTED TO TAKE CORTICOID (DELTACORTEN 25MG 1 TBT A DAY) AS ADVICED BY THE LOCAL MEDICAL EXPERT. THE PATIENT HAS A HISTORY OF FILLER INJECTIONS WITH TEOXANE PRODUCTS WITHOUT ANY ISSUES. ACCORDING TO THE INJECTOR, THE PATIENT WOULD HAVE REACTED TO THE LIDOCAIN IN THE FILLER. HOWEVER, THE LOCAL MEDICAL EXPERT THOUGH THAT THE PATIENT RATHER REACTED TO ONE OF THE EXCIPIENTS OF THE ANESTHETIC CREAM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19339875 ↗
• InjuryMar 22, 2024Use of Device Problem; Use of Device Problem

  THIS CASE OCCURED OUTSIDE OF THE USA, IN AUSTRALIA. THE AUSTRALIAN AFFILIATE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 19-MAR-2024. A PATIENT WAS INJECTED WITH 0.5 ML OF TEOSYAL RHA 2 IN THE LIPS. THE SAME DAY, DURING THE INJECTION, THE PATIENT EXPERIENCED BLANCHING IN THE LEFT UPPER LIP. THE CAPILARI REFILL WAS ANALYZED AND APPEARED TO BE SUPERIOR TO FIVE SECONDS. THE INJECTOR DIAGNOSED THE SYMPTOMS AS A VASCULAR OCCLUSIN OF MODERATE INTENSITY, AND A FIRM MASSAGE WAS DONE, BUT NO IMPROVEMENT WAS OBSERVED. THEREFORE, THE INJECTOR TREATED THE PATIENT WITH HYALURONIDASE ON THE UPPER LIP. FOLLOWING THIS TREATMENT, ALL THE FILLER WAS DISSOLVED, AND THE PATIENT COMPLETELY RECOVERED.  THE COMPLAINT WAS CONSIDERED CLOSED.

  Patient problems: Foreign Body Embolism

  MAUDE report 18959514 ↗
• InjuryJan 26, 2024Use of Device Problem; Use of Device Problem

  THUS CASE IS A CASE OCCURED OUTSIDE OF THE USA IN ITALY. THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 09-JAN-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH A TOTAL OF 1 ML OF RHA 2 IN THE NASOLABIAL FOLDS (0.2 ML), ORAL COMMISSURES (0.2 ML), LIP CONTOUR (0.2 ML), LOWER LIP (0.2 ML), AND CHEEK WRINKLES (0.2 ML). THE INJECTION WAS DONE WITH THE NEEDLE PROVIDED IN THE BOX USING FANNING AND LINEAR RETROGRADE TECHNIQUES. THE PATIENT HAD A HISTORY OF FACIAL TREATMENTS WITH BOTOX, HYALURONIC ACID FILLER, AND REVITALIZATION IN (B)(6) 2023. 5 HOURS AFTER THE INJECTION, THE PATIENT EXPERIENCED DISCOMFORT, A WHITE HALO, AND HERPES-LIKE BUBBLES. THESE SYMPTOMS WERE DIAGNOSED AS ISCHEMIA BY THE INJECTOR AND WERE TREATED WITH 300 IU OF HYALURONIDASE ON THE LEFT SIDE OF THE LOWER LIP. 2 DAYS LATER, ON (B)(6) 2024, THE PATIENT WAS TREATED WITH AN ADDITIONAL 300 I.U. OF HYALURONIDASE AND WAS FOLLOWED ON A DAILY BASIS. ON 08-JAN-2024, THE INJECTOR NOTICED TISSUE INJURIES AND OTHER HERPETIC INJURIES. ON 16-JAN-2024, WE WERE INFORMED THAT THE ISCHEMIA HAD IMPROVED, BUT THE PATIENT WAS NOW SUFFERING FROM SEVERE HERPES REACTIVATION DUE TO THE FILLER. FROM (B)(6) 2024, THE PA

  Patient problems: Foreign Body Embolism

  MAUDE report 18586244 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE THE USA, IN UNITED KINGDOM. ON 17-DEC-2023, THE UNITED KINGDOM SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON 23-SEP-2023 WITH 1ML OF TEOSYAL RHA 2 IN THE LIPS (UPPER AND LOWER) AND LIP OUTLINE. FEW DAYS LATER, ON 28-SEP-2023, THE PATIENT COMPLAINED ABOUT SLIGHT NUMB SENSATION IN THE LIPS, BUT WAS PLEASED WITH THE RESULT. ON 30-SEP-2023, THE CLINIC REACHED OUT TO THE PATIENT AND SHE ALSO REPORTED THAT SHE HAD SOME BRUISING (UNKNOWN DATE) WHICH HAS RESOLVED. SHE WAS ASKED TO SEND PHOTOS, BUT DIDN'T WANT TO, AS SHE SAID THAT IT LOOKED GOOD AND WAS NOTHING TO SEE. ON 08-NOV-2023, THE PATIENT HAD AN APPOINTMENT WITH HER DENTIST WHO ADVISED HER THAT WAS A PALPABLE LUMP TO THE RIGHT UPPER LIP AND ADVISED HER TO BOOK A REVIEW WITH THE INJECTOR. HE ALSO ADVISED HER THAT THE FEELING OF NUMBNESS COULD BE NERVE DAMAGE. SHE CALLED THE CLINIC AND REPORTED HAVING A LUMP SLIGHTLY TO THE UPPER RIGHT LIP WITH NUMBNESS THAT WAS AFFECTING HER SPEECH. SHE WANTED THE LUMP DISSOLVED. THEREFORE ON 10-NOV-2023, THE INJECTOR REVIEWED HER AND ADVISED THAT DERMAL FILLERS ARE NOT REPORTED TO CAUSE PARAESTHESIA IN THE LIP.

  Patient problems: Nerve Damage

  MAUDE report 18464685 ↗
• InjuryNov 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A GERMAN PHYSICIAN REPORTED TO TEOXANE AN ADVERSE EVENT ON (B)(6) 2023. A FEMALE PATIENT WAS INJECTED ON (B)(6) 2023 WITH 1ML OF TEOSYAL RHA 2 IN THE NASOLABIAL FOLDS AND CORNERS OF THE MOUTH. THE INJECTIONS WERE DONE WITH NEEDLES PROVIDED IN THE BOX USING A RETROTRACING TECHNIQUE. THE EVENING OF (B)(6) 2023, AN ADVERSE REACTION BEGAN IN THE AREA ABOVE THE RIGHT UPPER LIP, RIGHT NASOLABIAL FOLD GOING UPWARDS. THE PATIENT FELT PAIN, LIMITED SENSITIVITY, DIFFICULTY TO MOVE THE MOUTH, AND PRESENTED A BLUE/PALE COLOURATION. INITIAL TREATMENT INCLUDED APPLYING ARNICA SALVE AND ANTI-INFLAMMATORY MEDICATION (IBUPROFEN). IN THE MORNING OF (B)(6) 2023, THE PATIENT REACTION BECAME WORSE WITH MORE SEVERE PAIN. THE REACTION APPEARED TO BE A VASCULAR OCCLUSION. THE TEOXANE LOCAL MEDICAL EXPERT WAS CONTACTED BY THE PHYSICIAN INJECTOR; THE FORMER PROVIDED TREATMENT RECOMMENDATIONS BUT THE INJECTOR WAS UNABLE TO TREAT THE PATIENT. GIVEN THE URGENCY OF THIS CASE, TEOXANE GMBH COMMISSIONED A PHYSICIAN WHO IS NEAR THE PATIENT, WHO IMMEDIATELY TREATED HER WITH: - (B)(6) 2023 - EXAMINATION WITH ULTRASOUND AND HYALURONIDASE (1'200 IU), THEN PRESCRIPTION FOR ASPIRIN (100), IBUPROFEN (400), AND ANTIBIOTIC

  Patient problems: Embolism/Embolus; Foreign Body Embolism

  MAUDE report 18179967 ↗
• InjuryJul 3, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A NATUROPATH NOTIFIED TEOXANE OF AN ADVERSE EVENT ON (B)(6) 2023. A FEMALE PATIENT WAS INJECTED ON (B)(6) 2023 WITH 1ML OF TEOSYAL RHA 2 IN THE PERIORAL AREAS, LIPS, AND LABIAL COMMISSURES. THE INJECTION WAS DONE WITH THE NEEDLE PROVIDED IN THE BOX AND A CANNULA. THREE (3) DAYS AFTER, ON (B)(6) 2023, THE PATIENT PRESENTED A SERIES OF SIGNS AND SYMPTOMS IN AND AROUND THE RIGHT UPPER LIP (SKIN DISCOLOURATION, REDNESS, SWELLING, PAIN) THAT WERE CAUSED BY A VASCULAR OCCLUSION ACCORDING TO THE LOCAL MEDICAL EXPERT MANDATED ON THIS CASE. THIS MEDICAL EXPERT WAS ALSO PUT IN CONTACT WITH THE NATUROPATH INJECTOR TO PROVIDE TREATMENT RECOMMENDATIONS. THEY WERE THE FOLLOWING: DISSOLVE FILLER WITH HYALURONIDASE (2 AMPOULES AT 150 IU), CORTICOSTEROIDS (BREDNESOLON 50MG FOR 3-4 DAYS), ANTIBIOTICS (AMOXICLAV 2X1). THE PATIENT WAS ALSO REFERRED TO HER GENERAL PRACTITIONER. BASED ON INFORMATION RECEIVED ON 14-JUN-2023, THE REPORTER IN THIS CASE APPEARS LOST TO FOLLOW-UP. IT IS KNOWN THAT, AS OF (B)(6) 2023, THE ADVERSE EVENT WAS PARTIALLY RESOLVED.

  Patient problems: Foreign Body Embolism

  MAUDE report 17245412 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURRED IN THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON AN UNKNOWN EXACT DATE IN (B)(6) 2022, IN THE TEAR TROUGHS WITH A RHA 2 PRODUCT. A TOTAL OF 1ML OF RHA 2 WAS INJECTED, 0.5 CC TO EACH EYE. ON THE DAY OF THE INJECTION, THE PATIENT EXPERIENCED PARTIAL OCULAR OCCLUSION AT THE TEAR TROUGHS, AS WELL AS BLANCHING UNDERNEATH THE EYE, TOWARDS THE MEDIAL TEAR TROUGH. THERE WAS NO VISION CHANGE AND NO PAIN. AS CORRECTIVE TREATMENTS, THE PATIENT RECEIVED ASA, HEAT, MASSAGE, NITROPASTE AND HYALURONIDASE. ON THE SAME DAY THE PATIENT WAS ALSO SENT TO THE HOSPITAL WHERE SHE RECEIVED HYPERBARIC OXYGEN TREATMENT FOR 5 DAYS. AT THE TIME OF THIS REPORT, THE EVENT WAS RESOLVING. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Embolism/Embolus; Foreign Body Embolism

  MAUDE report 15904960 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURRED IN THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED ON 24-NOV-2021, A PATIENT WAS INJECTED ON (B)(6) 2021 WITH A RHA 2 PRODUCT TO THE FOREHEAD. ON AN UNKNOWN EXACT DATE, BETWEEN (B)(6) 2021 AND 21-NOV-2021, THE PATIENT PRESENTED WITH A VASCULAR OCCLUSION. ADDITIONALLY, THE PHYSICIAN NOTICED BLACK AND PINK DISCOLORATION AS WELL AS SOME BLISTERED LOOKING TISSUE, FROM THE MIDDLE THIRD OF HER FOREHEAD GOING UP TO THE HAIRLINE. AS CORRECTIVE TREATMENTS, THE PATIENT RECEIVED ANTIBIOTICS AND STEROIDS. AS CORRECTIVE TREATMENTS, THE PATIENT RECEIVED ANTIBIOTICS AND STEROIDS. DESPITE SEVERAL ATTEMPTS TO FOLLOW UP, NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Foreign Body Embolism

  MAUDE report 13078064 ↗