RHA® 4 RHA® 4 US 1.2ml Schott/2 needles TSK 27G1/2Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 07640173232704), received between May 5, 2022 and Jun 13, 2025 — classified as 47 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (20 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 47 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT OCCURED OUTSIDE OF THE USA, IN SPAIN. ON 01-OCT-2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT.  ACCORDING TO THE INFORMATION RECEIVED ON 01-OCT-2024, A PATIENT WAS INJECTED ON (B)(6) 2023 WITH: - 2,4 ML OF PURESENSE ULTRA DEEP IN CHEEKBONES WITH A BOLUS TECHNIQUE AND A CANNULA (RC/2410006) - 1,2 ML OF RHA 4 IN THE CHEEKS AND MARIONETTE LINES WITH A RETROTRACING TECHNIQUE (CURRENT COMPLAINT). APPROXIMATELY 11 MONTHS AFTER THE INJECTION, ON (B)(6)N2024, THE PATIENT REPORTED A MILD OEDEMA IN THE RIGHT TEAR TROUGH. THE SAME DAY, THE PATIENT RECEIVED THE FOLLOWING TREATMENTS: ANTIBIOTIC TREATMENT (DOXYCYCLINE - 100MG/12 HOURS - 10 DAYS) - GLUCOCORTICOID TREATMENT (ZAMENE - 15MG WITH A DECREASING DOSE ALONG TIME - UNSPECIFIED DURATION). 8 DAYS AFTER THE LAST CONSULTATION, ON (B)(6) 2024, THE PATIENT PRESENTED INFLAMMATORY NODULES IN MARIONETTE LINES LINKED TO THE RHA 4 INJECTION (CURRENT COMPLAINT). DURING THE CONSULTATION, THE PATIENT PROVIDED AN ULTRASOUND REPORT THAT MENTIONED A REACTION TO A FOREIGN BODY. THE INJECTOR DECIDED TO DISSOLVE THE FILLER IN THE RIGHT TEAR TROUGH AND MARIONETTE LINES WITH 100UI OF HYALURONIDASE AND THE ON-GOING TREATMEN

  Patient problems: Granuloma

  MAUDE report 20425842 ↗
• InjurySep 18, 2024Biofilm coating in Device; Biofilm coating in Device

  THIS CASE OCCURRED OUTSIDE OF THE USA, IN SPAIN. THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 15-AUG-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH THE FOLLOWING PRODUCTS: 1 ML OF TEOSYAL PURESENSE ULTRA DEEP IN THE MIDDLE THIRD AND CHEEKBONES, (RC/2408032). 1.2 ML OF RHA 4 IN THE NASOLABIAL FOLDS, LABIOMENTALIS GROOVE, AND IN THE CHEEKS (CURRENT COMPLAINT). OTHER PRODUCTS (RHA3, AND TEOSYAL PURESENSE REDENSITY 2) WERE INJECTED ON THE SAME DAY BUT NO ADVERSE EVENTS WERE REPORTED AT THESE INJECTION SITES. THE PATIENT ALSO HAD A HISTORY OF TEOXANE INJECTIONS WITH THE SAME PRODUCTS IN 2023 IN THE MIDDLE THIRD, NALOLABIALFOLDS, AND MAROINETTE LINES WITHOUT ANY ISSUE. APPROXIMATIVELY 3 MONTHS AFTER THE INJECTION, ON (B)(6) 2024 (THE DATE NEEDS TO BE CONFIRMED BECAUSE OF CONTRADICTORY INFORMATION), THE PATIENT NOTICED MILD FACIAL INFLAMMATION ACCOMPANIED BY INDURATION ON CHEEKBONES, ESPECIALLY ON THE RIGHT SIDE. THE PATIENT NOTICED IT WHILE BEING ON THE BEACH AND WHILE DOING SPORTS, AND THE SYMPTOM WAS CONFIRMED ON (B)(6) 2024 DURING A CONSULTATION. THE PATIENT WAS PRESCRIBED A TAPERING DOSE OF CORTICOSTEROID (PREDNISONE 30 MG) FOR 12 DAYS, AN ANTIBIOTIC (CIPRO

  Patient problems: Skin Infection

  MAUDE report 20246526 ↗
• InjuryAug 20, 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 (B)(6) 2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED WITH: - ON (B)(6) 2024: 1.2ML OF TEOSYAL PURESENSE ULTRA DEEP INTO THE MALAR AREA (BOLUS WITH THE NEEDLE 27G, RC/2408007), - ON (B)(6) 2024 : 2ML OF RHA 4 INTO THE CHEEKBONES AND MARIONETTE LINES (BOLUS + RETROGRADE INJECTION, CURRENT COMPLAINT), - ON (B)(6) 2024: 3ML OF TEOSYAL PURESENSE REDENSITY 1 INTO THE DERMIS OF A UNKNOWN AREA (RETROGRADE INJECTION, RC/2408008), - ON (B)(6) 2024: 1.2ML OF RHA 4 INTO THE CHEEKBONES AND NASOLABIAL FOLDS (CURRENT COMPLAINT), - ON A UNKNOWN DATE: 1ML OF TEOSYAL PURESENSE REDENSITY 2 INTO TEAR TROUGH, UPPER LIPS AND PERIORAL LINES (RC/2408006). APPROXIMATELY 1 MONTH AFTER THE LATEST INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED TWO INFLAMMATORY NODULES (ONE INTO THE LEFT TEAR TROUGH AND THE SECOND INTO THE LEFT MARIONETTE LINE), SOFT AND PAINFUL TO PALPATION, PLUS AN ERYTHEMA INTO THE LEFT TEAR TROUGH. ON (B)(6) 2024, LE PATIENT CONSULTED HER INJECTOR AND STARTED A TREATMENT BY PREDNISONE 1MG/KG/DAY. ON (B)(6) 2024, THE PATIENT SAW AGAIN HER INJECTOR AND RECEIVED INTRALESIONAL HYALURONIDA

  Patient problems: Skin Infection

  MAUDE report 20008677 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE USA, IN UNITED KINGDOM. THE UK SUBSIDIARY NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT ON (B)(6) 2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 2 SYRINGES OF RHA 4 ON UNKNOWN AREAS. THE INJECTION WAS DONE WITH THE RETROTRACING TECHNIQUE. THE DAY AFTER, ON (B)(6) 2024, THE PATIENT WAS TREATED WITH BOTULINUM TOXIN WITHOUT ISSUE. APPROXIMATELY 10 DAYS AFTER THE INJECTION (DATE WAS NOT PRECISED), THE PATIENT EXPERIENCED LUMP AND SWELLING ON THE RIGHT JAWLINE. AS TREATMENT, THE PATIENT WAS PRESCRIBED ANTIBIOTICS (AMOXICILIN 500) FOR 1 WEEK, AS WELL AS TAPERED STEROIDS (PREDNISONE) FOR 5 DAYS (40, 30, 20, 10). ON (B)(6).2024, THE INJECTOR VISITED THE PATIENT AND NOTICED THAT THE LUMP/SWELLING WAS STILL PRESENT. THEREFORE, A NEW ANTIBIOTIC (FLUCLOXILIN) WAS PRESCRIBED FOR 4 DAYS. THE LOCAL MEDICAL EXPERT WAS CONTACTED TO PROVIDE SUPPORT ON THIS CASE AND DIAGNOSED THE CASE AS AN INFECTION AT THE RIGHT MANDIBULAR ANGLE. ACCORDING TO HIM, THE LESION NEEDED TO BE INCISED AND DRAINED. HE ALSO RECOMMENDED PRESCRIBING A DUAL COURSE OF ANTIBIOTICS (CIPROFLOXACILIN 500 MG AND DOXICYCLIN 100 MG) FOR 10 DAYS AND POSSIBLY DISSOLVING THE FILLER AFTER THE RESOLUTION

  Patient problems: Skin Infection

  MAUDE report 19989297 ↗
• InjuryAug 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURRED OUTSIDE THE USA, IN GREECE. THE GREEK DISTRIBUTOR NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 18-JUL-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.8 ML OF TEOSYAL RHA 4 IN THE FACIAL OVAL (JAWLINE, TEMPLES). THE INJECTION WAS DONE WITH THE NEEDLE PROVIDED IN THE BOX, USING THE BOLUS TECHNIQUE. ONE MONTH LATER, ON (B)(6) 2024, THE PATIENT ALSO RECEIVED BOTULINUM TOXIN INJECTION ON UNKNOWN SITE. AROUND ONE MONTH AFTER THE RHA 4 INJECTION AND FEW DAYS AFTER THE BOTOX INJECTION, AROUND (B)(6), PATIENT EXPERIENCED 39 DEGREES FEVER. THE PATIENT WENT TO THE HOSPITAL ON THE (B)(6) AND STAYED THERE FOR 8 DAYS. AT THIS TIME, HER CRP WAS HIGH, AND A LYMPHADENITIS ACCOMPANIED WITH INFLAMMATION IN THE LEFT OBLIQUE CERVICAL SUBMANDIBULAR AREA WAS NOTICED. AN INCISION, WASHOUT (WITH BETADINE, PEROXIDE AND NORMAL SALINE) AND DRAINAGE (PENROSE DRAIN) OF THE AREA WAS CONDUCTED: 3CM INCISION PARALLEL AND 2CM BELOW THE MANDIBLE DOWN TO SUPERFICIAL FASCIA OF NECK. THE HISTOLOGICAL EXAMINATION REVEALED FIBROFATTY TISSUE (1.7X0.3X0.3X) WITHOUT TRACE OF HYALURONIC ACID BUT EVIDENCE OF CHRONIC INFLAMMATION AND NEOVASCULARIZATION (HYPEREMIA OF THE VESSELS). THE WOUND WAS CLOSED POST-SU

  Patient problems: Skin Infection

  MAUDE report 19969858 ↗
• InjuryAug 9, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  (B)(6) NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 10-JUL-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH: 1 ML OF RHA REDENSITY IN THE PERIORAL LINES. THE INJECTION WAS DONE WITH A 31G NEEDLE (COMPLAINT (B)(4). 1.2 ML OF RHA 4 IN THE CHEEKBONE. THE INJECTION WAS DONE WITH A 27G NEEDLE (CURRENT COMPLAINT). APPROXIMATELY THREE WEEKS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT RECEIVED MMR VACCINE (VACCINE AGAINST MEASLES, MUMPS, AND RUBELLA). 2 WEEKS LATER, ON (B)(6) 2024, THE PATIENT NOTED SWELLING. AT THIS TIME HCP INITIATED PATIENT ON PREDNISONE 40 MG, COLCHICINE, AND KEFLEX DAILY. THE DAY AFTER, ON (B)(6) 2024 SHE VISITED THE EMERGENCY ROOM DUE TO SWELLING THAT CAUSED DIFFICULTY BREATHING AND RECEIVED IV STEROID. THE PATIENT NOTICED SOME IMPROVEMENT OVER THE WEEK AFTER THE TREATMENT BUT ON 09-JUL-2024 THE PATIENT REPORTED HARD NODULES AND SWELLING. THE SWELLING WAS MORE CONCENTRATED IN AREAS WHERE THE FILLER WAS PLACED (UNKNOWN WHETHER RHA REDENSITY OR RHA 4), AND ACCORDING TO THE HCP, SOME GENERALIZED SWELLING WAS PRESENT AS WELL. BASED ON THE INFORMATION THE RELATEDNESS OF THE DIFFICULTY TO BREATH WITH THE INJECTION OF TEOXANE PRODUCTS COULD NOT BE EXCLUDED. THUS, THE CASE

  Patient problems: Dyspnea

  MAUDE report 19947301 ↗
• 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 : - (B)(6) 2024 WITH 0.8ML OF RHA 2 IN THE TEAR TROUGHS ((B)(4)).. - (B)(6) 2024 WITH 0.8ML OF RHA 4 IN THE CHEEKBONES (CURRENT COMPLAINT). - (B)(6) 2024 WITH 1.4ML OF TEOSYAL PURESENSE ULTRA DEEP IN THE CHEEKBONES ((B)(4)). ON (B)(6) 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 (B)(6) 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 PE

  Patient problems: Skin Infection

  MAUDE report 19938730 ↗
• InjuryAug 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS CASE OCCURRED OUTSIDE OF THE USA, IN THE UNITED KINGDOM. THE UK SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 09-JUL-2024. ON (B)(6) 2024, A 59-YEAR-OLD FEMALE PATIENT WAS INJECTED WITH A TOTAL OF 6.2 ML OF RHA 4 (2.4 ML IN THE NASOLABIAL FOLDS, 1.6 ML IN THE ORAL COMMISSURES, 0.6 ML IN THE CHIN AND 0.8 ML IN EACH SIDE OF PRE JOWL SULCUS) WITH 25G CANNULA AND NEEDLE SUPPLIED IN THE BOX USING A FANNING TECHNIQUE (WITH CANNULA) WITH INJECTION ONTO BONE. OTHER PRODUCTS (TEOSYAL PURESENSE RHA KISS 0.7 ML WAS INJECTED ON THE SAME DAY AND ON (B)(6) 2024 IN THE LIPS WITH NEEDLE PROVIDED IN THE BOX USING A MULTIPUNCTURE TECHNIQUE AND TEOSYAL PURESENSE REDENSITY 1, 1ML WAS INJECTED ON (B)(6) 2024 IN BLEBS TO SKIN SUPERFICIALLY AROUND ORAL COMMISURE WITH 4MM NEEDLE TSK USING MULTIPUNCTURE TECHNIQUE) BUT NO ADVERSE EVENTS WERE REPORTED AT THESE INJECTION SITES. THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY AND WAS NOT TAKING ANY MEDICATION AT THE TIME OF THIS REPORT. ON (B)(6) 2024, ABOUT TWO MONTHS AFTER THE INJECTION, THE PATIENT DEVELOPED SEVERE OEDEMA, ERYTHEMA, PAIN AND INFLAMMATION IN ALL SITES INJECTED WITH RHA 4. THE INJECTOR CONSIDERED THE EVENT AS AN INFECTION/CELL

  Patient problems: Cellulitis

  MAUDE report 19936362 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE USA, IN THE UNITED KINGDOM. THE UK SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 09-JUL-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH RHA 4 ON BOTH CHEEKS (0.15 ML ON EACH SIDE). THE INJECTION WAS DONE WITH THE BOLUS TECHNIQUE (4 INJECTIONS ON EACH CHEEK), USING THE NEEDLE PROVIDED IN THE BOXE. THE PATIENT HAD A HISTORY OF UNKNOWN SKIN TREATMENT IN (B)(6) 2023, AS WELL AS FACE LIFT AND BLEPHAROPLASTY IN (B)(6) 2023. THE MEDICAL HISTORY OF THE PATIENT ALSO MENTIONED RAYNAUD'S DISEASE AND HYPOTHYROIDISM, FOR WHICH SHE WAS TAKING THYROXIN. IN ADDITION, (B)(6) 2024, THE PATIENT SUFFERED FROM SHINGLES.  3 DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED DISCOMFORT, HEAT, AND REDNESS OF MODERATE INTENSITY ON THE LEFT CHEEK ONLY. THIS WAS ACCOMPANIED BY A MILD SYSTEMIC UPSET (SHE FELT TIRED AND DIZZY) BUT NORMAL OBSERVATION. 7 DAYS LATER, ON (B)(6) 2024, THE PATIENT COMPLAINED ABOUT FURTHER REDNESS AND SWELLING DIFFUSELY OF THE RIGHT CHEEK. THE SYMPTOMS APPEARED INFERIOR TO THE AREA TREATED. AT THIS STAGE, THE SYMPTOMS WERE DIAGNOSED AS A SOFT TISSUE INFECTION. AS TREATMENT, THE PATIENT WAS PRESCRIBED ANTIBIOTICS (FLUCLOXACI

  Patient problems: Abscess

  MAUDE report 19926148 ↗
• InjuryJul 18, 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 18-JUN-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 1 ML OF RHA 4 IN THE MID-CHEEK USING AN UNSPECIFIED NEEDLE. ON THE SAME DAY, THE PATIENT ALSO RECEIVED BOTULINUM TOXIN (XEOMIN) AT AN UNSPECIFIED SITE. THE DAY AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT WENT TO THE ER AND WAS HOSPITALIZED FOR 2 DAYS, FROM (B)(6) 2024 TO (B)(6) 2024, DUE TO PUFFY EYES AND SWOLLEN LIPS AND CHEEKS. IT WAS NOTED THAT THE SWELLING IN THE LEFT CHEEK WAS "10 TIMES" WORSE THAN THE RIGHT CHEEK. AN ALLERGIC REACTION WAS FIRST DIAGNOSED. IN THE MEANTIME, A CT SCAN WAS PERFORMED ON (B)(6) 2024 AND SHOWED FLUID ACCUMULATION. THE PATIENT WAS PRESCRIBED STEROIDS AND AN ORAL ANTIBIOTIC ON AN UNSPECIFIED DATE AS TREATMENT. AND ON (B)(6) 2024 HYALURONIDASE (HYLENEX) WAS INJECTED UNDER ULTRASOUND GUIDANCE. ACCORDING TO THE REPORTER, THIS PROCEDURE EXACERBATED THE SWELLING. ON (B)(6) 2024, THE PATIENT WAS READMITTED TO THE HOSPITAL. A CAT SCAN PERFORMED ON THE SAME DAY SHOWED FLUID ACCUMULATION. ACCORDING TO THE INJECTOR, AN INFECTION WAS THEN SUSPECTED. THE INFECTIOUS DISEASE SERVICE WAS CONSULTED, AND THE PATIENT RECEIVED ANTIBIOTICS INTRAVENOUSLY.

  Patient problems: Skin Infection

  MAUDE report 19769065 ↗
• InjuryJun 4, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THIS EVENT OCCURED OUTSIDE OF THE USA, IN ITALY. THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 06-MAY-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH A TOTAL OF 0.4 ML OF RHA 4 IN THE NOSE (0.2 ML ON THE TIP AND 0.2 ML IN THE NASAL SPINE). THE INJECTIONS WERE DONE WITH THE BOLUS TECHNIQUE USING THE NEEDLE PROVIDED IN THE BOX. 2 DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT EXPERIENCED HYPOPERFUSION ACCOMPANIED BY EPIDERMOLYSIS ON THE RIGHT NASAL WING. THE PATIENT WAS TREATED WITH HYALURONIDASE: ON (B)(6) 2024 800 I.U. ON (B)(6) 2024 700 I.U. ON (B)(6) 2024, THE INJECTOR CONTACTED THE LOCAL MEDICAL EXPERT, WHO DIAGNOSED THE SYMPTOMS AS NECROSIS. IN AGREEMENT WITH THE MEDICAL EXPERT, THE PATIENT WAS FURTHER TREATED WITH HYALURONIDASE AS FOLLOWS: ON (B)(6) 2024 600 I.U. ON (B)(6) 2024 450 I.U. ON (B)(6) 2024 300 I.U. IN ADDITION, THE PATIENT WAS PRESCRIBED THE FOLLOWING TREATMENTS: ANTIBIOTIC (AUGMENTIN 2 TBT FOR 5 DAYS) CORTICOID (BENTELAN, 4 G, 2 TIMES A DAY) NON-STEROID ANTI-INFLAMMATORY DRUG (ASPIRINE 500 MG, 2 TIMES A DAY) PROTON PUMP INHIBITOR (PANTORC 40 MG ONCE A DAY FOR 10 DAYS) FROM (B)(6) 2024, THE PATIENT ALSO APPLIED TOPICAL THERAPY TO PROMOTE HE

  Patient problems: Foreign Body Embolism; Necrosis

  MAUDE report 19457113 ↗
• InjuryMay 23, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THIS CASE OCCURED OUTSIDE THE USA, IN SPAIN. ON 10-MAY-2024, THE SPANISH SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.15ML OF TEOSYAL RHA 4 IN THE NOSE (0.1ML IN THE NASAL BONE AND 0.05ML IN THE COLUMELLA). IMMEDIATELY AFTER THE INJECTIONS, ON (B)(6) 2024, THE PATIENT PRESENTED WITH A WHITENING OF THE LEFT NASAL WING. THE INJECTOR APPLIED DIRECTLY 3 CYCLES OF HYALURONIDASE, 300 IU EVERY HALF HOUR, AND DRY HEAT. THE AREA HAS REPERFUSED. THE INJECTOR REQUESTED CONTROL PHOTOS AFTER 3 DAYS ; THE PHOTOS WERE NORMAL. ON (B)(6) 2024, 9 DAYS AFTER THE INJECTIONS, THE PATIENT PRESENTED WITH VESICLES IN THE AREA OF THE NASAL BONE AND WHITE LIP. THE PATIENT ALSO REPORTED THAT THE UPPER LIP AND THE INNER MUCOSA HAD WOUNDS. SHE DIDN'T CONTACT THE INJECTOR SOONER AS SHE THOUGHT IT WAS HERPES. THEREFORE, ON (B)(6) 2024, THE INJECTOR TREATED AGAIN THE AREA WITH 2 CYCLES OF HYALURONIDASE INJECTIONS 300IU AND PRESCRIBED ANTIBIOTIC (AMOXICILLIN 500MG EVERY 8 HOURS). ON (B)(6) 2024 THE PATIENT RECEIVED ADDITIONAL INJECTIONS OF HYALURONIDASE (500IU). ADDITIONALLY A MEDICAL ASSISTANCE WAS PROVIDED. THE LOCAL MEDICAL EXPER

  Patient problems: Embolism/Embolus; Foreign Body Embolism

  MAUDE report 19381084 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCUREDE OUTSIDE OF THE USA, IN ITALY. THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 24-APR-2024. A PATIENT WAS INJECTED WITH SEVERAL TEOXANE PRODUCTS AS FOLLOWS:  - ON (B)(6) 2023 WITH (CURRENT COMPLAINT) IN THE CHEEKBONES (HALF OF THE VIAL ON EACH SIDE), - ON (B)(6) 2023 WITH RHA 3 (RC/2404123) IN THE NLF (HALF OF THE VIAL ON EACH SIDE), - ON (B)(6) 2023 WITH PURESENSE REDENSITY 2 IN THE TEAR TROUGH (HALF OF THE VIAL ON EACH SIDE), - ON (B)(6) 2023 WITH RHA 4 (CURRENT COMPLAINT) IN THE MALAR AREA (0.6 ML ON EACH SIDE). 4 MONTHS AFTER THE LAST INJECTION, ON 26-MAR-2024, THE PATIENT REPORTED SMALL NODULES AND SLIGHT SWELLING ON THE LEFT SIDE NEAR THE NOSE AND THE RIGHT SIDE ON THE MALAR AREA.  2 WEEKS LATER, APPROXIMATELY ON (B)(6) 2024, THE SWELLING INCREASED AND WAS ACCOMPANIED BY REDNESS IN THE SAME AREAS. THE INJECTOR ADVISED THE PATIENT TO DO AN ULTRASOUND.  ON (B)(6) 2024, AN ULTRASOUND WAS DONE IN BELGIUM (THE COUNTRY OF THE PATIENT) AND CONFIRMED THE PRESENCE OF GRANULOMA.  AS TREATMENT, THE PATIENT TOOK ANTIBIOTICS (UNKNOWN TYPE) AND CORTISONE IN (B)(6) 2024 (UNKNOWN EXACT DATE). THE SYMPTOMS IMPROVED. THE LOCAL MEDICAL EXPERT WAS CONTACTE

  Patient problems: Granuloma

  MAUDE report 19379510 ↗