RHA® 4 RHA® 4 (1mL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640173230069), received between Mar 17, 2022 and Mar 4, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse 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 (B)(6)2025, THE SPANISH SUBSIDIARY INFORMED TEOXANE GENEVA ABOUT AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6)2024 WITH THE FOLLOWING PRODUCTS: - 2.4 ML OF PURESENSE ULTRA DEEP: 1.2ML IN CHEEKS, CHEEKBONES AND CHIN AND 1.2 ML IN THE JAWLINES (RC/2502020). - 4.4 ML OF RHA 4: 0.8 ML IN THE CHEEKS, 1.2 ML IN CHEEKBONES, 1.2 ML IN MARIONETTE LINES AND 1.2 ML IN JAWLINE/MANDIBULA (CURRENT COMPLAINT). THE PATIENT HAD HISTORY OF PREVIOUS INJECTIONS OF HYALURONIC ACID (UNSPECIFIED), OF BIOSTIMULATOR (RADIESSE), BOTOX AND CARBOXYTHERAPY IN THE PAST (UNDEFINED DATES) AND EXPERIENCED GRANOLUMAS DUE TO RADIESSE PRODUCT. SHE ALSO HAD A DENTAL TREATMENT ON (B)(6)2025 AND WAS TAKING COLAGEN AND VITAMINS AS MEDICATIONS DURING THE INJECTION. APPROXIMATELY 2,5 MONTHS AFTER THE INJECTION, ON (B)(6)2025, THE PATIENT EXPERIENCED SKIN INDURATION AND ERYTHEMA IN THE PERI ORBITAL AREA, DIAGNOSED AS CELLULITIS OF MODERATE INTENSITY. ONE DAY AFTER, ON (B)(6)2025, THE PATIENT EXPERIENCED NODULES OF MODERATE INTENSITY IN THE MANDIBULA AND IN THE CHIN. THE PATIENT WAS PRESCRIBED THE FOLLOWING TREATMENTS ON (B)(6)2025:

  Patient problems: Cellulitis

  MAUDE report 21512779 ↗
• InjuryOct 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURRED OUTSIDE OF THE USA, IN ITALY. THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 25-SEP-2024. A PATIENT WAS INJECTED WITH 0.4 ML OF RHA 4 ON THE TIP OF THE NOSE ON (B)(6) 2024. 7 MONTHS LATER, ON (B)(6) 2024, THE PATIENT PRESENTED WITH REDNESS ON THE TIP OF THE NOSE OF MODERATE INTENSITY. AS MEDICAL TREATMENT ON 24-SEP-2024, THE PATIENT WAS PRESCRIBED THE FOLLOWING : - KELAIRON CREAM, 1 TIME IN THE MORNING AND 1 TIME IN THE EVENING, STARTING FOR 7 DAYS; - GENTALIN BETA CREAM, 1 TIME IN THE MORNING AND 1 TIME IN THE EVENING, STARTING FOR 7 DAYS. THE LOCAL MEDICAL EXPERT WAS CONTACTED TO PROVIDE SUPPORT IN THIS CASE. ON 08-OCT-2024, WE WERE INFORMED THAT THE CASE WAS DIAGNOSED AS A VASCULAR COMPRESSION BY THE LOCAL MEDICAL EXPERT ON AN UNKNOWN DATE. A TREATMENT WITH 30 I.U. OF HYALURONIDASE WAS ADVISED. BASED ON THIS DIAGNOSIS, THE CASE WAS UPGRADED AS REPORTABLE TO THE HEALTH COMPETENT AUTHORITIES. ON (B)(6) 2024, THE PATIENT WAS TREATED WITH 35 I.U. OF HYALURONIDASE IN THE NOSE AND EVOLVED FAVORABLY. ON (B)(6) 2024, ONLY A LITTLE REDNESS WAS REMAINING. THE INJECTOR PLANNED TO SEE THE PATIENT AT THE END OF OCTOBER TO DETERMINE IF AN ADDITIONAL INJECTIO

  Patient problems: Foreign Body Embolism

  MAUDE report 20523761 ↗
• InjuryNov 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON OCTOBER 31, 2023, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT FOLLOWING THE USE OF TEOSYAL RHA 4 IN A PATIENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2023, WITH 1 ML OF TEOSYAL RHA 4 IN THE NASOLABIAL FOLDS. THE INJECTION WAS PERFORMED WITH A NEEDLE USING THE BOLUS TECHNIQUE. THREE DAYS AFTER THE INJECTION, ON (B)(6) THE PATIENT EXPERIENCED A VASCULAR COMPROMISE, AS SHE PRESENTED WITH NECROSIS AND PUSTULES IN THE RIGHT NASOLABIAL FOLD AND RIGHT UPPER LIP, AS WELL AS SKIN DISCOLOURATION IN THE RIGHT UPPER LIP. ON THE SAME DAY, THE PRACTITIONER INJECTED 2.5 VIALS OF HYALURONIDASE (500 IU EACH). ON OCTOBER 31, ONE OF OUR LOCAL MEDICAL EXPERTS CONTACTED THE INJECTOR TO PROVIDE ADVICE ON THE MANAGEMENT OF THIS EVENT. ON NOVEMBER 6, WE RECEIVED TWO PICTURES AND A VIDEO OF THE PATIENT. WE WERE INFORMED THAT SHE UNDERWENT A HYPERBARIC CHAMBER SESSION ON (B)(6) AND SHE WAS EVOLVING FAVORABLY. FINALLY, ON NOVEMBER 21, WE WERE INFORMED THAT THE PATIENT HAD RECOVERED. A MILD SKIN DISCOLOURATION REMAINED, WHICH WAS PLANNED TO BE TREATED WITH LASER. THUS, WE CONSIDER THIS CASE AS CLOSED.

  Patient problems: Foreign Body Embolism

  MAUDE report 18225788 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT OCCURED OUTSIDE THE USA, IN CROATIA. ON (B)(6) 2023, AN INJECTOR FROM CROATIA NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2023 WITH 1.2ML OF TEOSYAL RHA 4 DISTRIBUTED BILATERALLY IN THE MIDFACE REGION (CHEEKS AND DEEP PYRIFORM FOSSA). FOLLOWING THE INJECTION, ON THE SAME DAY, THE PATIENT PRESENTED WITH A VASCULAR OCCLUSION. THE INJECTOR REPORTED THAT AFTER TREATING THE LEFT SIDE OF THE FACE AND FINISHING OFF WITH THE LEFT DEEP PYRIFORM FOSSA, SHE NOTICED MOTTLING OF THE SKIN AND BLUISH DISCOLORATION IN THE AREA OF DISTRIBUTION OF THE ANGULAR ARTERY. THE BLUISH DISCOLORATION PROGRESSED TO THE TIP OF THE NOSE. THE INJECTOR TESTED THE CAPILLARY REFILL TIME AND NOTICED IT WAS REDUCED. IMMEDIATELY, THE INJECTOR DECIDED TO PROCEED WITH HYALURONIDASE INJECTIONS (PREVIOUS ALLERGY TESTED), ACCORDING TO HIGH PULSE PROTOCOL. THE PATIENT RECEIVED IN TOTAL OF 3 AMPOULES OF HYALURONIDASE 1500 IU WITH 30 MINUTES OF INTERVAL OVER A PERIOD OF 6 HOURS. A CLINICAL IMPROVEMENT WAS NOTICED IMMEDIATELY. THE NEXT DAY, THE PATIENT RECEIVED ANOTHER INJECTION OF HYALURONIDASE, BECAUSE SOME MILD MOTTLING WAS STILL NOTICED IN THE NASOLABI

  Patient problems: Embolism/Embolus; Foreign Body Embolism

  MAUDE report 17963729 ↗
• InjuryOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA, IN AUSTRALIA. A NURSE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON (B)(6) 2023. A PATIENT WAS INJECTED WITH: - 2 ML OF TEOSYAL RHA 3 IN THE CHIN (MENTALIS CREASE) AND IN THE MARIONETTE LINES ON (B)(6) 2023. THE INJECTION WAS DONE WITH A CANNULA, USING THE FANNING TECHNIQUE. ONE DAY AFTER THE INJECTION, ON (B)(6) 2023, THE PATIENT PRESENTED WITH A VASCULAR OCCLUSION (SLUGGISH CAP REFILL), BIG LUMP, PAIN, AND EXTENDING BRUISING (CONSIDERED AS A SKIN DISCOLOURATION) OF SEVERE INTENSITY, IN THE RIGHT LOWER LIP AND IN THE RIGHT MARIONETTE AREA. ON (B)(6) 2023, THE PATIENT PRESENTED WITH INFLAMMATION OF LOW INTENSITY IN THE RIGHT LOWER LIP. ACCORDING TO THE INFORMATION RECEIVED ON 05-OCT-2023, THE INJECTOR PROVIDED THE FOLLOWING MEDICAL TREATMENT TO THE PATIENT: A VIAL OF HYALASE 1500 I.U TO THE CHIN, LIP AND MARIONETTE LINES FOR 60 MINUTES ON (B)(6) 2023, A VIAL OF HYLASE 30 I.U, ON (B)(6) 2023. A VIAL OF HYALASE 600 I.U, ON (B)(6) 2023. ZYRTEC (AN ANTIHISTAMINIC), UNKNOWN QUANTITY, ON (B)(6) 2023. ON 09-OCT-2023, WE WERE INFORMED THAT ALL THE SYMPTOMS RESOLVED. THE COMPLAINT WAS CONSIDERED CLOSED.

  Patient problems: Foreign Body Embolism

  MAUDE report 17905566 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE THE US, IN UNITED KINGDOM. ON 30-AUG-2023, AN INJECTOR FROM UNITED KINGDOM NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2023 WITH 1.2ML OF TEOSYAL RHA 4 IN THE MARIONETTE LINES AND IN THE CHIN (BOLUS AND FANNING TECHNIQUE). AROUND 6 WEEKS AFTER THE INJECTIONS, ON (B)(6) 2023, THE PATIENT PRESENTED WITH SWELLING AND SOLID FILLER IN THE MARIONETTE LINES (BOTH SIDES), WITHOUT PAIN OR HEAT. THE PATIENT RECEIVED AS TREATMENT : HYALURONIDASE INJECTIONS : 1500IU ON (B)(6) 2023, 1500 IU ON (B)(6) 2023 AND 1500IU ON (B)(6) 2023. ANTIBIOTICS (CLARITHROMYCIN 500MG AND CIPROFLOXACIN 500MG) ON (B)(6) 2023. ACCORDING TO THE INJECTOR, THE PATIENT SEEMED TO BE RESPONDING WELL TO HYALURONIDASE. THEN, ANOTHER ADVERSE REACTION APPEARED AFTER THE THIRD SESSION AND THE INJECTOR SUSPECTED A CELLULITIS. ADDITIONALLY, THE LOCAL MEDICAL EXPERT WAS PUT IN CONTACT WITH THE PRACTITIONER TO ADVICE ON THIS CASE. ACCORDING TO THE FOLLOW UP INFORMATION RECEIVED ON 26-SEP-2023, THE PATIENT HAD BEEN TREATED FOR CELLULITIS AND THE INJECTOR REACHED OUT TO THE MEDICAL EXPERT FOR FURTHER ADVICE. DESPITE SEVERAL REMINDERS, NO INFORMATI

  Patient problems: Cellulitis; Skin Inflammation/ Irritation

  MAUDE report 17842917 ↗
• InjuryJul 19, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON JULY 7, 2023, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT FOLLOWING THE USE OF TEOSYAL RHA 4 IN A PATIENT. ACCORDING TO THE INFORMATION RECEIVED, THE INJECTOR PERFORMED A NON-SURGICAL RHINOPLASTY AND INJECTED 0.4 ML OF TEOSYAL RHA 4 IN THE "PATIENT'S" NOSE AND NASAL COLUMELLA TO SUPPORT THE TIP OF THE NOSE ON (B)(6) 2023. ONE DAY AFTER THE INJECTION, ON (B)(6) 2023, THE PRACTITIONER NOTICED A VASCULAR COMPROMISE WITH SYMPTOMS OF ECCHYMOSIS, WHITENING, AND PAIN ON THE UPPER GUMS, CAUSED BY A PUNCTURE OF THE COLUMELLAR ARTERY. AS A CORRECTIVE ACTION, 1000 UI OF HYALURONIDASE WERE IMMEDIATELY ADMINISTERED, AND THE FOLLOWING TREATMENT WAS PRESCRIBED: INTRAMUSCULAR CORTICOSTEROIDS: URBASON 60 MG. ORAL CORTICOSTEROIDS: PREDNISONE 10 MG (ONCE EVERY 8 HOURS). NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: ASPIRIN 300 MG (1 TABLET) AND ASPIRIN 100 MG (1 TABLET EVERY 12 HOURS). WARM COMPRESSES. VASODILATOR: SILDENAFIL 50 MG (ONCE A DAY). FINALLY, ON THE SAME DAY, WE WERE INFORMED THAT THE VASCULAR COMPROMISE WAS FULLY RESOLVED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: Foreign Body Embolism

  MAUDE report 17350171 ↗
• InjuryJul 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT FOLLOWING THE USE OF TEOSYAL RHA 4 IN A PATIENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2023, WITH 1.2 ML OF TEOSYAL RHA 4 IN THE NASOLABIAL FOLDS. THE INJECTION WAS DONE USING THE RETROTRACING TECHNIQUE. ON THE SAME DAY, THE PATIENT EXPERIENCED A VASCULAR COMPROMISE, AS HE PRESENTED WITH LIVEDO RETICULARIS, PAIN, AND INFLAMMATION ON THE LEFT NASOLABIAL FOLD, AS WELL AS FEVER. AS A CORRECTIVE ACTION, 200 IU OF HYALURONIDASE WERE ADMINISTERED ON (B)(6) 2023, AND ANTIBIOTICS (AZITHROMYCIN 500 MG, 1 TABLET PER DAY) WERE PRESCRIBED. ON (B)(6) 2023, WE WERE INFORMED THAT THE PATIENT HAD GONE TO THE EMERGENCY ROOM ON (B)(6) 2023, AS HE STILL SUFFERED FROM FEVER AND INTENSE PAIN. THE INJECTOR STATED THAT THERE WERE NO SIGNS OF NECROSIS IN THE PICTURE. ON (B)(6) 2023, OUR MEDICAL ADVISOR INSISTED ON THE NEED TO INJECT MORE HYALURONIDASE. ON (B)(6) 2023, WE WERE INFORMED THAT, ALTHOUGH THE PATIENT DID NOT COME BACK FOR HIS CONSULTATION, THE INJECTOR FOUND OUT THAT HE WAS COMPLETELY FINE. AS IT APPEARED IN THE PHOTOS, THIS ADVERSE EVENT WAS LIKELY A MILD VASCULAR COMPROMISE, INDUCED BY INF

  Patient problems: Foreign Body Embolism

  MAUDE report 17332124 ↗
• InjuryJul 3, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON JUNE 20, 2023, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT FOLLOWING THE USE OF TEOSYAL RHA 4 IN A PATIENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2023, WITH 0.6 ML OF TEOSYAL RHA 4 IN THE NASOLABIAL FOLDS. THE INJECTION WAS DONE WITH A NEEDLE USING THE RETROTRACING TECHNIQUE. ON THE SAME DAY, THE PRACTITIONER NOTICED A VASCULAR COMPROMISE, AS THE PATIENT PRESENTED WITH LIVEDO RETICULARIS ON THE NOSE, THE LEFT NASOLABIAL FOLD AND THE WHITE LIP. AS A CORRECTIVE ACTION, 600 UI OF HYALURONIDASE WERE IMMEDIATELY ADMINISTERED (FOUR INJECTIONS OF 150 UI) AND THE FOLLOWING TREATMENT WAS PRESCRIBED: - NONSTEROIDAL ANTI-INFLAMMATORY DRUG (ASPIRIN 300 MG): 1 TABLET. - TOPICAL ANTIBIOTIC: (MUPIROCIN 2%): TWICE A DAY FOR 7 DAYS. ONE DAY AFTER THE INJECTION, ON (B)(6) 2023, ANOTHER 1500 UI OF HYALURONIDASE WERE ADMINISTERED (ONE INJECTION), AND THE FOLLOWING TREATMENT WAS PRESCRIBED: - NONSTEROIDAL ANTI-INFLAMMATORY DRUG (ASPIRIN 100 MG): 1 TABLET PER DAY FOR 7 DAYS. FINALLY, ON JUNE 20, 2023, WE WERE INFORMED THAT THE VASCULAR COMPROMISE WAS FULLY RESOLVED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: Foreign Body Embolism

  MAUDE report 17246460 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION RECEIVED ON FEB. 14, 2023, A PATIENT WAS INJECTED IN THE END OF (B)(6) 2023 (UNSPECIFIED DATE) WITH 0.4 ML OF RHA 4 INTO THE BILATERAL CHEEKS. APPROXIMATELY 3 WEEKS POST-INJECTION, THE PATIENT EXPERIENCED SORENESS AND SWELLING, ACCOMPANIED BY TENDERNESS ALL OVER INJECTED AREA. THE EMERGENCE OF A POSSIBLE CELLULITIS WAS SUSPECTED BY THE PRACTITIONER. THEREFORE, ON (B)(6) 2023, AS A CORRECTIVE ACTION, AN ANTIBIOTIC TREATMENT (CEFALEXIN; KEFLEX) WAS PRESCRIBED. FOLLOWING THIS INITIAL REPORT, A LOCAL MEDICAL EXPERT WAS MANDATED TO PROVIDE THE CLINICAL ASSESSMENT AND ADVICE ON THIS CASE. AS PER THE MEDICAL EXPERT NOTES, THE EMERGENCE OF CELLULITIS IS RATHER RELATED TO THE PROCEDURE INCLUDING THE EXPOSURE OF THE SKIN TO DIFFERENT PATHOGENS, HOWEVER, THIS COULD ALSO BE RELATED TO THE SECONDARY INFECTION DUE TO INJECTION SITE INFLAMMATION ASSOCIATED WITH DERMAL FILLER TREATMENT. THEREFORE, BASED ON THE CHARACTERISTIC OF THIS EVENT, THE CASE WAS CONSIDERED TO BE REPORTABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S SITUATION, AND SYMPTOM'S EVOLUTION ARE MONITORED.

  Patient problems: Skin Infection

  MAUDE report 16529704 ↗
• InjuryMar 17, 2022Patient-Device Incompatibility

  ACCORDING TO THE INFORMATION RECEIVED ON 14-FEB-2022, A PATIENT WAS INJECTED ON (B)(6) 2022 WITH A RHA 4 PRODUCT TO EACH CHEEK. DURING THE INJECTION, THE PATIENT FELT INTERMITTENT HEADACHE PAIN, WHICH LASTED FOR A FEW DAYS. AS CORRECTIVE TREATMENT SHE WAS RECOMMENDED TO TAKE TYLENOL. INSTANTLY AFTER THE INJECTION, THE PATIENT EXPERIENCED CONSIDERABLE BRUISING AND WAS PRESCRIBED ARNICA GEL. IN ADDITION, THAT SAME AFTERNOON, THE PATIENT EXPERIENCED BLURRED VISION IN BOTH EYES, WHICH LASTED ALL DAY AND IMPROVED IN THE NEXT MORNING. THE PATIENT ALSO REPORTED SOME WEAKNESS ALL OVER THE BODY, TINGLING IN THE ARMS, AS WELL AS TIREDNESS. THE PATIENT WAS CONCERNED THAT THIS MIGHT BE A STROKE BUT THE DIAGNOSIS WAS NOT CONFIRMED BY A HEALTHCARE PROFESSIONAL. THE PATIENT WAS RECOVERING FROM THE BRUISING, THE WEAKNESS AND THE TINGLINGS AND RECOVERED FROM THE BLURRED VISION. FINAL : FOLLOWING INTERNAL DISCUSSIONS WITH A US MEDICAL EXPERT, THIS CASE WAS DOWNGRADED TO NON-SERIOUS. INDEED, THE EVENT OF STROKE IS THE PATIENT'S SUBJECTIVE ASSUMPTION AND WAS NOT CONFIRMED BY ANY HCP.

  Patient problems: Visual Disturbances

  MAUDE report 13794558 ↗