RHA 4Recalls & reported problems across all models

We found 4 models of RHA 4 by Teoxane SA in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2022 and Nov 13, 2025 — classified as 60 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RHA 4 problems

RHA 4 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RHA® 4 RHA® 4 US 1.2ml Schott/2 needles TSK 27G1/2

  Implant, Dermal, For Aesthetic Use
  47 reports
• RHA® 4 RHA® 4 (1mL)

  Implant, Dermal, For Aesthetic Use
  11 reports
• RHA® 4 RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2

  Implant, Dermal, For Aesthetic Use
  1 report
• RHA® 4 RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2

  Implant, Dermal, For Aesthetic Use
  1 report

Recent RHA 4 adverse event reports

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

• InjuryNov 13, 2025Off-Label Use; Off-Label Use

  WIDESPREAD SKIN CONDITION/ SYSTEMIC REACTION [SKIN REACTION] RH4 IN THE TEAR TROUGH CHEEKS LIPS [OFF LABEL USE] VISION LOSS TEMPORARILY/FUZZY VISION/FILM LIKE FEELING ON EYE/SPORADIC ¿FLARE UP¿ OF VISION AND A FOGGY FEELING EYE [VISUAL IMPAIRMENT] REDNESS [INJECTION SITE ERYTHEMA] PAIN/TENDER WHEN PRESSED [INJECTION SITE PAIN] TINGLING UNDEREYES [INJECTION SITE PARAESTHESIA] FEVER/INTENSE HEAT [INJECTION SITE WARMTH] HARD LUMP//UNEVEN UNDEREYE/DISFIGURED UNDEREYE/LUMPY [INJECTION SITE MASS] FULLNESS BENEATH LEFT ORBIT/OEDEMA/SWELLING, EYE WILL SWELL UP LIKE IT HAS MIGRATED [INJECTION SITE OEDEMA] HARD LUMP [INJECTION SITE INDURATION] CASE NARRATIVE: ON 09-JUN-2025, PRIMEVIGILANCE FROM USA NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED FROM THE CAREGIVER (NURSE) A FEMALE PATIENT WAS INJECTED ON (B)(6) 2025 WITH RHA 4 (1-2 SYRINGES) IN THE TEAR TROUGH, CHEEKS AND LIPS WITH A NEEDLE BY A PHYSICIAN. THE PATIENT HAD A HISTORY OF: - JUVEDERM VOLUMA INJECTION ON (B)(6) 2023 (UNKOWN INDICATION) - UNKOWN RHA PRODUCT INJECTION ON (B)(6) 2023 (UNKOWN INIDCATION) - ALLERGY TO ERYTHROMYCIN SINCE (B)(6) 1999, WHICH CAUSES VOMITING. ON AN UNSPECIFIED DATE, THE

  Patient problems: Visual Disturbances

  MAUDE report 23541998 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15-MAY-2025, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED WITH RHA 4: - ON (B)(6) 2022: 1,2 ML IN THE CHEEKBONES USING THE BOLUS TECHNIQUE AND THE NEEDLE PROVIDED IN THE BOX (27G/13MM). - ON (B)(6) 2022: 1,2 ML IN THE MARIONETTE LINES USING THE RETROTRACING TECHNIQUE AND A CANNULA. APPROXIMATELY 3 YEARS AFTER THE INJECTIONS, ON (B)(6) 2025, THE PATIENT PRESENTED FOR CONSULTATION COMPLAINING OF GENERALIZED FACIAL OEDEMA OF ONE MONTH'S DURATION. THE INJECTOR NOTED THE PRESENCE OF INDURATED NODULES IN THE LABIOMENTAL AREA AND DIAGNOSED A DELAYED INFLAMMATORY REACTION IN THE CHEEKBONES. THE FOLLOWING TREATMENT WAS PRESCRIBED: - ON (B)(6) 2025: HYALURONIDASE 1500 UI. - ON (B)(6) 2025: CORTICOIDS (PREDNISONE 60MG PER DAY FOR 3 DAYS). - ON (B)(6) 2025: ANTIBIOTICS (DOXYCYCLIN 100MG PER DAY FOR 21 DAYS) AND ANTIHISTAMINES (EBASTINE 20MG PER DAY FOR 15 DAYS). AS A PRESEPTAL CELLULITIS WAS SUSPECTED, PATIENT WAS ALSO SENT TO AN ENT SPECIALIST. CT SCAN REVEALED INDURATED MASSES IN THE CHEEKBONE AREA EXTENDING MEDIALLY AND INFRAORBITALLY IN THE LEFT CHEEKBONE AND A SOFTER MASS IN THE RIGHT CHEEKBONE, OF APPROXIMATELY 3 X 2 CM IN SIZE. INDURATED

  Patient problems: Skin Infection

  MAUDE report 22200932 ↗
• InjuryJun 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA IN AUSTRALIA. ON 03-DEC-2024, THE AUSTRALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED ON 12-JAN-2025, A PATIENT WAS INJECTED WITH THE FOLLOWING PRODUCTS: 1.2 ML OF RHA 4 IN BOTH MID CHEEKS ON (B)(6) 2024 USING A BD SYRINGE AND THE BOLUS TECHNIQUE (CURRENT COMPLAINT). 1.8 ML OF ULTRA DEEP IN BOTH CHEEKS (0.8 ML) ON (B)(6) 2024 AND CHIN (1ML) USING A BD SYRINGE AND THE BOLUS TECHNIQUE (RC/2501030). 1.0 ML OF RHA 3 IN THE LIPS ON (B)(6) 2024 USING A BD SYRINGE AND THE BOLUS AND FANNING TECHNIQUES. (RC/2501031). 10 DAYS LATER, ON (B)(6) 2024, THE PATIENT EXPERIENCED DROPPY RIGHT EYE (POSSIBLE EYELID PTOSIS). THE PATIENT WAS PRESCRIBED EYE DROPS (PILOCARPINE), WAS ADVISED TO NOT TOUCH THE EYE. APPROXIMATELY 1 MONTH LATER, ON (B)(6) 2024, THE EYE SYMPTOMS IMPROVED AND THE EYE DROPS WERE STOPPED. THE INTERNATIONAL MEDICAL EXPERT WAS CONTACTED FOR GUIDANCE REGARDING THE PTOTIS, AND ACCORDING TO THE INFORMATION RECEIVED ON 30-JAN-2025, THIS CASE MIGHT BE EVENTUALLY A CASE OF OPHTHALMOPLEGIA FOLLOWING HA FILLERS INJECTIONS, WITHOUT VISION LOSS OF OTHER SYMPTOMATOLOGY AS HA FILLERS CAN ACCIDENTALLY DECRE

  Patient problems: Movement Disorder

  MAUDE report 22184580 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS A FOREIGN CASE OUTSIDE THE USA, IN UNITED KINGDOM. ON 25-MAR-2025, THE MHRA AUTHORITY NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED WITH: 0.9 ML OF TEOSYAL PURESENSE ULTRA DEEP IN THE CHEEKS ON (B)(6) 2025 USING THE BOLUS TECHNIQUE AND WITH THE NEEDLE SUPPLIED IN THE BOX. (RC/2503091). 2.4 ML OF RHA 4 IN THE CHEEKS, NASOLABIAL FOLDS, ORAL COMMISSURES, CHIN AND JAW ON (B)(6) 2025 USING THE BOLUS, RETROTRACING AND FANNING TECHNIQUES AND WITH THE NEEDLE SUPPLIED IN THE BOX. (CURRENT COMPLAINT). UNSPECIFIED QUANTITY OF RHA 3 IN THE NASOLABIAL FOLDS AND MARIONETTE LINES ON (B)(6) 2023 (RC/2504004). DURING 3 WEEKS AFTER THE LAST INJECTIONS, THE PATIENT DID NOT EXPERIENCE ANY REACTION. ON (B)(6) 2025, THE PATIENT EXPERIENCED FIRMNESS OF THE FILLER AND REPORTED THAT THE FILLER WAS "ODD/STRANGE/UNUSUAL". THE INJECTOR WAS NOT ABLE TO RECEIVE THE PATIENT FOR A CONSULTATION BUT ADVISED ANTI HISTAMINIC TREATMENT (FEXOFENADINE). ONE DAY AFTER, ON (B)(6) 2025, THE PATIENT EXPERIENCED A WHOLE FACE SWELLING AND FIRMNESS OF SEVERE INTENSITY CAUSING DIFFICULTY TO OPEN THE MOUTH (DUE TO TIGHTNESS). THE PATIENT WENT TO THE ER

  Patient problems: Swelling/ Edema

  MAUDE report 21854601 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TIS CASE OCCURED OUTSIDE OF USA IN PORTUGAL. ON (B)(6) 2025, THE SPANISH/PORTUGUESE SUBSIDIARY NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT OCCURRING IN PORTUGAL. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS INJECTED ON (B)(6) 2023 WITH 1.2 ML OF RHA 4 IN THE CHEEKS AND SHE RECEIVED HARMONYCA LIDOCAINE TREATMENT THE SAME DAY IN THE PERIORAL AREA. ON (B)(6) 2025 THE PATIENT HAD A DENTAL IMPLANT AND RECEIVED AN ANTI-INFLAMMATORY TREATMENT ON THE FOLLOWING DAY STARTED ON (B)(6) 2025. APPROXIMATELY ONE WEEK LATER, ON (B)(6) 2025, THE PATIENT EXPERIENCED OEDEMA, ERYTHEMA AND INDURATION IN MALAR AREA ON THE LEFT SIDE. APPROXIMATELY 2 WEEKS LATER, ON (B)(6) 2025, THE PATIENT EXPERIENCED THE SAME SYMPTOMS ON THE RIGHT SIDE AND WAS PRESCRIBED ANTIBIOTIC TREATMENT (AMOXICILLIN/CLAVULANIC ACID 875 MG/125 MG). 12 DAYS LATER, ON (B)(6) 2025, A GRANULOMATOUS REACTION IN THE BUCCAL AREA WAS DIAGNOSED WITH ANATOMO-PATHOLOGICAL EXAMINATION AND THE PATIENT WAS PRESCRIBED GLUCOCORTICOIDS (PREDNISOLONE). CONSIDERING THE DIAGNOSIS, THIS CASE WAS ASSESSED AS SERIOUS AND REPORTABLE. ADDITIONALLY, THE PATIENT WAS TAKING SEVERAL MEDICATIONS FOR UNDEFINED RHEUMATIC DISEASE. ON (B)(6) 2025 ALL SY

  Patient problems: Granuloma

  MAUDE report 21854037 ↗
• 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 ↗
• InjuryFeb 25, 2025Improper 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 OCCURED OUTSIDE OF THE USA IN SPAIN. ON 21-MAY-2024, THE SPANISH DISTRIBUTOR NOTIFIED US OF AN ADVERSE EVENT. HOWEVER THE EMAIL WAS LOST AND THIS CASE WAS OPENED ONLY ON 27-JAN-2025 THANKS TO A REMINDER FROM THE SPANISH SUBSIDIARY. A NON CONFORMITY (NCR-000001312) HAS BEEN THEREFORE OPENED FOR THIS LATE OPENING OF RC/2501064. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH RHA 4 IN THE NOSE (RADIX AND TIP OF THE NOSE) . THE SAME DAY THE PATIENT EXPERIENCED A WRONG CAPILLARY REFILL IN THE NASAL TIP AND RECEIVED HYALURONIDASE INJECTIONS (3000UI + 500UI IN WHITE LIP AND COLUMNELLA). AFTER THE INJECTION OF HYALURONIDASE, THE PATIENT EXPERIENCED A LIVEDO IN THE GLABELLA AND IN THE WHITE LIP. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC TREATMENT (MUPIROCIN 2%) FOR 7 DAYS AND AINS TREATMENT (ADIRO 100) 7 DAYS. THE DAY AFTER, ON (B)(6) 2024, THE PATIENT RECEIVED A NEW INJECTION OF HYALURONIDASE (500 UI) IN THE NASAL DORSUM. A LOCAL MEDICAL EXPERT WAS CONTACTED FOR GUIDANCE AT THIS TIME AND ACCOMPANIED THE INJECTOR WITH THE INJECTION OF HYALURONIDASE. ACCORDING TO THE INFORMATION RECEIVED ON 27-JAN-2025, THE SYMPTOMS WERE RESOLVED A FEW DAYS AFTER TH

  Patient problems: Foreign Body Embolism

  MAUDE report 21460476 ↗
• InjuryJan 29, 2025Use of Device Problem; Use of Device Problem

  THIS CASE OCCURED OUTSIDE OF THE USA IN AUSTRALIA. ON (B)(6)2024, THE AUSTRALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6)2024 WITH THE FOLLOWING PRODUCTS: - 1.2 ML OF RHA 4 IN BOTH CHEEKS USING A 25 G CANNULA AND RETROTRACING TECHNIQUE (CURRENT COMPLAINT). - 1.2 ML OF ULTRA DEEP IN BOTH CHEEKS USING THE NEEDLE SUPPLIED IN THE BOX AND THE BOLUS TECHNIQUE (B)(6). APPROXIMATELY 5 MONTHS AFTER THE INJECTIONS, ON (B)(6)2024, THE PATIENT EXPERIENCED A LUMP/NODULE OF 1-1.5 CM IN DIAMETER OF MODERATE INTENSITY IN THE RIGHT CHEEK AND INFORMED THE CLINIC OWNER ABOUT THE EVENT SHE WAS CONSIDERING AS A POTENTIAL LATE ONSET REACTION ON (B)(6)2024. THE PATIENT WAS ADVISED TO WAIT AND GOT AN APPOINTMENT WITH THE INJECTOR (NURSE) AND A DOCTOR ON (B)(6)2024. DURING THE APPOINTMENT THE PATIENT PRESENTED A NODULE ON THE RIGHT CHEEK, A SWELLING EXTENDED UNDER THE RIGHT EYE, AND PAIN AND PUSHING OF THE LUMP AFTER THE ASSESSMENT. THE PATIENT ALSO COMPLAINED ABOUT THE SIZE OF THE NODULE THAT WAS INCREASING WITH TIME. DURING THE APPOINTMENT, OBVIOUS ASYMMETRY IN THE CHEEKS WAS ALSO OBSERVED. DURING THE APPOINTMENT, THE

  Patient problems: Skin Infection

  MAUDE report 21262146 ↗
• InjuryDec 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA IN SPAIN. ON 15-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 0.3 ML OF RHA 4 IN THE MANDIBULAR ANGLES ON BOTH SIDES AND WITH 0.5 ML OF ULTRA DEEP IN THE CHEEKBONES. DURING THE INJECTION IN THE MANDIBULAR ANGLE, THE INJECTOR NOTICED THAT THE RIGHT SIDE OF THE LATERAL NOSE GOT A BIT WHITE, BUT SHE CHECKED THE CAPILLARITY REFILLED WHICH WAS NORMAL. THE INJECTION OF HYALURONIC ACID WAS STOPPED, BUT HYALURONIDASE WAS NOT INJECTED. THE SAME DAY, LATE AT NIGHT, THE PATIENT SENT SOME PICTURES, AND THE INJECTOR DIAGNOSED A LIVEDO RETICULARIS/ISQUEMIA REACTION OF SEVERE INTENSITY OF THE FACIAL ARTERY. A LOCAL MEDICAL EXPERT HAS BEEN CONTACTED AND CONFIRMED IT WAS A VASCULAR COMPROMISE OF THE FACIAL ARTERY. DURING THE FOLLOWING DAYS, THE INJECTOR HAS INJECTED A TOTAL OF 7.000 UI OF HYALURONIDASE FROM THE MANDIBULAR LINE TO THE NOSE, AND THE CAPILLARY REFILL RETURNED TO NORMAL. THE INJECTOR PRESCRIBED THE FOLLOWING TREATMENTS: - ANABOLIC ANDROGENIC STEROIDS, - CORTICOSTEROIDS (PREDNISONE), - ANTIBIOTICS (ORBENIN, CIPROFLOXACIN), - ORGANIC NITRAT

  Patient problems: Foreign Body Embolism

  MAUDE report 20890525 ↗
• InjuryNov 25, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE USA IN SPAIN. ON 28-OCT-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 0.8 ML OF RHA 4 IN THE NOSE (0.3 ML IN THE TIP OF THE NOSE, 0.5 ML IN THE UPPER PART OF THE NOSE). 8 DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED ERYTHEMA AND ULCERATION ON THE TIP OF THE NOSE, BOTH OF SEVERE INTENSITY, AND A POSSIBLE NECROSIS OF TISSUE IN THE TIP OF NOSE. A MEDICAL EXPERT WAS CONTACTED FOR GUIDANCE WHO THOUGHT IT WAS A VASCULAR COMPROMISE DUE TO HYALURONIC ACID COMPRESSION AND RECOMMENDED TO INJECT HYALURONIDASE, TO PRESCRIBE AN ANALGESIC TREATMENT (ADIRO) AND A TREATMENT CREAM FOR SKIN LESION (TOPICAL MUPIROCIN). 9 DAYS AFTER THE INJECTION, ON (B)(6) 2024 THE PATIENT WAS INJECTED WITH 2500 UNITS OF HYALURONIDASE, AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR THE WEEK AFTER. ACCORDING TO THE INFORMATION RECEIVED ON 12-NOV-2024, THE INJECTOR REMOVED THE FILLER WITH HYALURONIDASE AND PRESCRIBED A PROTOTYPICAL ANALGESIC TREATMENT (ADIRO) AND TOPICAL MUPIROCIN TO THE PATIENT. THE INJECTOR CONFIRMED THE CASE WAS CLOSED; THUS, THE CASE WAS

  Patient problems: Foreign Body Embolism

  MAUDE report 20770083 ↗
• InjuryNov 22, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THIS CASE OCCURED OUTSIDE OF THE US IN SPAIN. ON 25-OCT-2024, A DOCTOR FROM SPAIN NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.8 ML IN LIPS (0.6 ML IN UPPER LIP AND 0.2 ML IN LOWER LIP) WITH RHA4. OTHER UNSPECIFIED HA PRODUCTS WERE INJECTED ON (B)(6) 2019 AND ON (B)(6) 2022 IN LIPS, AND 1 ML OF KISS WAS ALSO INJECTED IN LIPS ON (B)(6) 2023, WITH NO INCIDENCE FOR THE PATIENT. IMMEDIATELY AFTER THE LAST INJECTION OF RHA 4, ON (B)(6) 2024, A HEMATOMA OF MODERATE INTENSITY APPEARED, AND THE SAME DAY A COMPRESSION OF THE LOWER LABIAL ARTERY WAS DIAGNOSED. CONSIDERING THE DIAGNOSIS OF VASCULAR SKIN DISORDER, THIS CASE IS SERIOUS AND REPORTABLE. 2 DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT RECEIVED AN INJECTION OF (B)(4) UNITS OF HYALURONIDASE AND WAS PRESCRIBED THE FOLLOWING TREATMENTS: GLUCOCORTICOIDS TREATMENT (DEFLAZACORT) FOR 7 DAYS; ANTIBIOTIC TREATEMENT (MUPIROCIN) FOR 7 DAYS; ASA (ASPIRINA/AUGMENTINA) FOR 10 DAYS. ACCORDING TO THE INFORMATION RECEIVED ON 26-OCT-2024, THE ADVERSE EVENT IS FULLY RESOLVED. THEN THE CASE WAS CLOSED.

  Patient problems: Foreign Body Embolism

  MAUDE report 20756948 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE US IN FRANCE. ON 17-OCT-2024, THE FRENCH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024, WITH RHA 4 IN NASOLABIAL FOLDS AND IN CHEEKBONES (1,2 ML PERSIDE) WITH A NEEDLE. THE SAME DAY THE PATIENT WAS INJECTED IN CHEEKBONES WITH UNKNOWN AMOUNT OF RHA 4. NO COMPLAINT WAS OPENED FOR THIS INJECTION CONSIDERING THE REACTION SITE. APPROXIMATELY 3 MONTHS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED SWELLING, LUMPS INSIDE THE CHEEKS, INDURATION AND CARDBOARD SKIN. ONE WEEK LATER, ON (B)(6) 2024, A SECONG PHASE OF SWELLING STARTED, WITH HIGHER INTENSITY. THE PATIENT WAS PRESCRIBED CORTISONE FOR 6 DAYS, ANTIBIOTHERAPY AND A CT SCAN EXAM. ONE WEEK LATER, ON (B)(6) 2024, THE PATIENT HAD DRAINAGE WITH CT SCAN ASSISTANCE, LIPOSUCTION, AND RINSING. THE PATIENT WAS STILL SWOLLEN. 9 DAYS LATER, ON (B)(6) 2024, THE PATIENT EXPERIENCED SWELLING. ACCORDING TO THE INFORMATION RECEIVED, THE INJECTOR REMOVED ALL NODULES AND ASKED FOR ANALYSIS. THE ANALYSIS CAME BACK AS NORMAL. ACCORDING TO SEVERAL MEDICAL DOCTORS, NO INFECTION WAS DIAGNOSED, ONLY AN INFLAMMATORY REACTION. AN AUTO-IMMU

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20694031 ↗
• InjuryNov 6, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 07-OCT-2024. A MALE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.2 ML OF RHA 4 IN THE MIDFACE. THE INJECTION WAS DONE WITH UNSPECIFIED NEEDLE. (GAUGE SIZE: 27). FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED A VASOVAGAL SYNCOPE. THE PATIENT RECOVERED AND REGAINED CONSCIOUSNESS WITHIN MINUTES. BASED ON THE INFORMATION RECEIVED, A VASOVAGAL SYNCOPE DUE TO TEOXANE PRODUCT INJECTION COULD NOT BE RULED OUT. THUS, THE CASE WAS ASSESSED AS REPORTABLE TO THE FDA. DESPITE SEVERAL REMINDERS, NO ADDITIONAL INFORMATION COULD BE RECEIVED. THUS, THE COMPLAINT WAS CLOSED AS IS. NO FURTHER INFORMATION WAS RECEIVED AT THIS STAGE. FURTHER ATTEMPTS WILL BE MADE TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Syncope/Fainting

  MAUDE report 20618812 ↗
• 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 ↗
• InjuryOct 17, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 18-SEP-2024. A FEMALE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 1 SYRINGE OF RHA 4 IN THE GONIAL ANGLE, PREJOWL SULCUS AND NASOLABIAL FOLDS (0.2 ON EACH SIDE GONIAL ANGLE AND 0.2 PREJOWL SULCUS AND 0.2 NASOLABIAL FOLDS). THE INJECTION WAS DONE WITH UNSPECIFIED NEEDLE. ON THE SAME DAY, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION IN THE JAWLINE. THE PATIENT WAS TREATED WITH MULTIPLE ROUNDS OF HYALURONIDASE (HYLENEX): 5 VIALS OF HYALURONIDASE (HYLENEX) FIRST DAY AND 2 VIALS ON THE NEXT DAY, ALONG WITH ASPIRIN AND WARM COMPRESSES. REVANCE MEDICAL AFFAIRS TEAM CONTACTED THE INJECTOR. THE SYMPTOMS OF VASCULAR OCCLUSION WERE CONSIDERED AS RESOLVED IN (B)(6) 2024. ACCORDING TO THE RESOLUTION OF THE SYMPTOMS, THE CASE WAS CLOSED.

  Patient problems: Embolism/Embolus

  MAUDE report 20470093 ↗

Other Teoxane SA products

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