RHA 3Recalls & reported problems across all models

We found 2 models of RHA 3 by Teoxane SA in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2021 and Feb 23, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 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 3 problems

RHA 3 models

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

• RHA® 3 RHA® 3 (1mL)

  Implant, Dermal, For Aesthetic Use
  31 reports
• RHA® 3 RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2

  Implant, Dermal, For Aesthetic Use
  1 report

Recent RHA 3 adverse event reports

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

• InjuryFeb 23, 2026Improper or Incorrect Procedure or Method

  SLUGGISH CAPILLARY REFILL - VASCULAR OCCLUSION [VASCULAR SKIN DISORDER] ([SKIN DISCOLOURATION], [LIVEDO RETICULARIS]). CASE NARRATIVE: ON 12-FEB-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED ON (B)(6) 2026 WITH 0,1ML OF RHA 3 IN THE PIRIFORM FOSSA USING THE NEEDLE PROVIDED IN THE BOX. IMMEDIATELY AFTER THE INJECTION (ON (B)(6) 2026), THE INJECTOR NOTICED A DARKENING DISCOLORATION IN THE PIRIFORM FOSSA EXTENDING TO THE NOSE. THE PATIENT RECEIVED 4 SESSIONS OF HYALURONIDASE (HYLENEX 75-250 IU). THE INITIAL DISCOLORATION WAS RESOLVING BUT RED AND WHITE LACE-LIKE PATTERN COULD BE SEEN IN THE UPPER LIP. SOME SLUGGISH CAPILLARY REFILL PERSISTED BUT WAS < 3 SECONDS TO RETURN TO BASELINE. CONSIDERING THE SERIOUSNESS OF THE EVENT, THE CASE WAS ASSESSED AS REPORTABLE. ON 17-FEB-2026, WE RECEIVED THE CONFIRMATION THAT THE SYMPTOMS WERE LINKED TO A VASCULAR OCCLUSION AND THAT THEY WERE RESOLVED. CONSIDERING RESOLUTION OF THE SYMPTOMS, THE CASE WAS CONSIDERED CLOSED. IMDRF CODE ANNEX G IS ERRONEOUS IS THIS CASE (DUE TO DATABASE ISSUE). PLEASE CONSIDER CODE G04127 ¿ SYRINGE.

  Patient problems: Foreign Body Embolism; Skin Discoloration

  MAUDE report 24412892 ↗
• InjurySep 16, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SEVERE ANGIOEDEMA / EXTREME SWELLING [ANGIOEDEMA] , STIFF FEELING IN LIPS / HARD / STIFFNESS / FIBROTIC TISSUE [SKIN INDURATION] , MULTIPLE HARD NODULES / LUMPS [NODULE] , DRY EYE [DRY EYE] . CASE NARRATIVE: ON (B)(6) 2025, A PATIENT FROM (B)(6) NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. THE LATER WAS INJECTED ON (B)(6) 2025 WITH 1 ML OF TEOSYAL RHA 3 IN THE LIPS USING THE BOLUS TECHNIQUE WITH THE NEEDLE SUPPLIED IN THE BOX. THE SAME DAY, THE PATIENT RECEIVED A FULL-FACE TREATMENT (EXCLUDING THE LIPS) WITH CYTOCARE (HYALURONIC ACID + REJUVENATING COMPLEX). TWO DAYS AFTER THE INJECTION, ON (B)(6) 2025, THE PATIENT EXPERIENCED MULTIPLE HARD NODULES/LUMPS, A STIFF FEELING, AND EXTREME SWELLING IN THE LIPS AS WELL AS DRY EYES. ON (B)(6) 2025, THE LIP FILLER WAS DISSOLVED WITH A FIRST COURSE OF HYALURONIDASE. ON (B)(6) 2025, SOME LUMPS REMAINED IN THE LIPS. ON (B)(6) 2025, SYMPTOMS GRADUALLY DISAPPEARED AND REMAINING LUMPS WERE VERY SMALL. CONSIDERINF THE ONGOING RESOLUTION OF THE SYMPTOMS, THE CASE WAS CONSIDERED CLOSED ON (B)(6) 2025. ON 05-SEP-2025, WE RECEIVED A MEDWATCH REPORT DIRECTLY FROM THE FDA (REFERENCE: MW5174104). ON WHICH, ON 29-JUL-2025 THE PATIENT REPORTED "TEOXANE LIP

  Patient problems: Angioedema

  MAUDE report 23064038 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2025, A PATIENT FROM UNITED KINGDOM NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. THE LATER WAS INJECTED ON (B)(6) 2025 WITH - 1 ML OF PURESENSE ULTRA DEEP IN THE LATERAL CHEEK (0,5 ML PER SIDE) USING THE FANNING TECHNIQUE AND A CANNULA FROM THE TEMPORAL HAIRLINE (ENTRY POINT) TO THE CHEEK, JAW AND TEMPLE ((B)(6)) - 1 ML OF RHA 3 IN THE MIDFACE (0,5 ML PER SIDE) (CURRENT COMPLAINT). - 2 ML OF A POLY-NUCLEOTIDE TREATMENT (AMI EYES PN) IN UNDER EACH EYE AREA (1 ML PER SIDE) USING A CANNULA. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED 6 DAYS AFTER THE INJECTION, ON (B)(6) 2025 A SIGNIFICANT SWELLING, TENDERNESS AND PAIN AT THE INJECTION SITE. ON (B)(6) 2025, SHE PRESENTED A PURULENT DISCHARGE REPORTED AS DEEP ABSCESS AT THE INJECTION SITE, REQUIRING EMERGENCY HOSPITAL CARE, INCISION AND DRAINAGE, AND SEVERAL HYALURONIDASE TREATMENTS AS DECRIBED BELOW: - (B)(6) 2025: FIRST DRAINAGE OF ABSCESS - (B)(6) 2025: ULTRASOUND CONFIRMED A DEEP ABSCESS OVERLYING THE ZYGOMATIC BONE - (B)(6) 2025: SECOND DRAINAGE PERFORMED - (B)(6) 2025: FIRST HYALURONIDASE TREATMENT - (B)(6) 2025: EMERGENCY ROOM FOLLOWING A SECOND PURULENT DISCHARGE, REDNESS AND SWELLING - (B)(6) 2025:

  Patient problems: Abscess

  MAUDE report 22292431 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23-MAY-2025, THE ITALIAN SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0,5 ML OF RHA 2 IN THE LIPS USING THE RETROTRACING TECHNIQUE AND THE NEEDLE PROVIDED IN THE BOX (30G/13MM). THE PATIENT HAD AN HISTORY OF PREVIOUS AESTHETIC PROCEDURE IN THE LIPS: ON (B)(6) 2023: TEOSYAL RHA 3 (GIVEN THE INJECTION DATE, NO OTHER COMPLAINT WAS OPENED FOR THIS TEOXANE PRODUCT). ACCORDING TO THE INFORMATION RECEIVED, ON (B)(6) 2025, THE PATIENT EXPERIENCED AN EPISODE OF VIRAL INFECTION (WITH FEVER AND VOMITING) AND THE NEXT DAY SHE STARTED TO HAVE SWELLING AND OEDEMA IN HER LIPS. DUE TO THE SEVERITY OF THE SYMPTOMS, THIS CASE WAS ASSESSED REPORTABLE. SHE WENT TO EMERGENCY ROOM WHERE SHE WAS PRESCRIBED CORTICOIDS (BENTELAN 1 MG) AND ANTIHISTAMINE TREATMENT (ZIRTEC) FOR 5 DAYS AND THE SYMPTOMS DISAPPEARED. ON (B)(6) 2025 IN THE EVENING A STRONG OEDEMA APPEARED AGAIN IN THE SAME AREA. A SECOND COURSE OF CORTICOIDS (CORTISONE) WAS PRESCRIBED AND THE SYMPTOMS IMPROVED BUT RETURNED AFTER THE STOPPING THE TREATMENT AND A THIRD COURSE OF CORTICOIDS WAS PRESCRIBED (BENTELAN TO SCALING THE DOSE: 2 MG, 2 MG, 2 MG, 1 MG AND 1 MG FOR 5 DAYS). ON (B)(6) 202

  Patient problems: Swelling/ Edema

  MAUDE report 22149605 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE USA IN ITALY. ON 04-APR-2025, THE ITALIAN 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 RHA 1 IN THE DÉCOLLETÉ USING THE RETROGRADING LINEAR TECHNIQUE AND THE NEEDLE SUPPLIED IN THE BOX (RC/2504020) 1 ML OF RHA 3 IN THE NASOLABIAL FOLDS USING THE RETROGRADING LINEAR TECHNIQUE AND THE NEEDLE SUPPLIED IN THE BOX (CURRENT COMPLAINT) RADIESSE IN THE CHEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED ABOUT THIS INJECTION. 7 DAYS AFTER THE INJECTIONS, ON (B)(6) 2024, THE PATIENT EXPERIENCED AN ANGIOEDEMA OF SEVERE INTENSITY AND THE PATIENT WENT TO EMERGENCY ROOM. BILATERAL CHEEKS AND EYELIDS SWELLING WAS REPORTED (MORE IMPORTANT ON THE LEFT SIDE), AS WELL AS HEAT AND PAIN. PATIENT ALSO EXPERIENCED TRISMUS PREVENTING MOUTH EXAMINATION DURING THE CONSULTATION. CONSIDERING THE SEVERITY OF THE CASE ON THE LOCALIZATION OF THE SYMPTOMS ASSESSED AS "SERIOUS" THIS CASE WAS ASSESSED AS REPORTABLE FOR RHA3 PRODUCT ONLY. BLOOD TESTS WERE PERFORMED SHOWING NEUTROPHILIC LEUKOCYTOSIS, OTHER INDICATORS INCLUDING CRP WERE WITHIN THE NORM. DURING THE CONSULTATION A SUSPEC

  Patient problems: Angioedema

  MAUDE report 21942418 ↗
• InjuryApr 22, 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. (RC/2503092). UNSPECIFIED QUANTITY OF RHA 3 IN THE NASOLABIAL FOLDS AND MARIONETTE LINES ON (B)(6) 2023 (CURRENT COMPLAINT). 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 A&E WHER

  Patient problems: Swelling/ Edema

  MAUDE report 21881941 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE OF THE USA IN AUSTRALIA. ON 12-FEB-2025, THE AUSTRALIA SUBSIDIARY NOTIFIED US OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 1 ML OF RHA 3 IN JOWL AND IN MARIONETTE LINES WITH A CANNULA (STERIGLIDE 0.50X38MM/25G) USING THE FANNING TECHNIQUE. APPROXIMATELY 3 WEEKS AFTER THE INJECTION THE PATIENT EXPERIENCED SEVERE PAIN STARTING FROM LATERAL CHEEK TO ALL THE MID-FACE ON THE RIGHT SIDE AND SEVERAL MONTHS LATER A SEVERE TRIGEMINAL NEURALGIA WAS DIAGNOSED BY A NEUROLOGIST. CONSIDERING THE SEVERITY OF THE EVENT AND THE DIAGNOSIS, THE CASE WAS ASSESSED AS REPORTABLE. ON (B)(6) 2025, A MEDICAL ASSISTANCE WAS PROVIDED AND DIFFERENTIAL ETIOLOGIES OF THE REACTION WERE EXPLAINED. THE MEDICAL EXPERT CONFIRMED A POSSIBLE CONTRIBUTION OF HA FILLER INJECTIONS TO TRIGEMINAL NEURALGIA-LIKE SYMPTOMS WEEKS LATER THROUGH SEVERAL POTENTIAL MECHANISMS. ACCORDING TO THE INFORMATION RECEIVED ON 05-MAR-2025, THE INJECTOR NEVER ANSWERED TO THE MEDICAL EXPERT, NEITHER THE SUBSIDIARY AND NO MORE INFORMATION WAS RETRIEVED. THEREFORE THE CASE WAS CLOSED AS THIS.

  Patient problems: Neuralgia

  MAUDE report 21595283 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2024, PRIME VIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED IN (B)(6) 2024 WITH 0,5 ML OF RHA 3 IN THE LIPS. IN (B)(6) THE PATIENT TRAVELED IN ITALY AND WAS SICK (SORE THROAT, STUFFY NOSE AND HEADACHE). ON (B)(6)2024, SHE CONSULTED HER INJECTOR AND STILL RECEIVED 0,5 ML OF RHA 3 IN THE LIPS. TWO DAYS AFTER (ON (B)(6)2024), THE PATIENT REPORTED (NOT MEDICALLY CONFIRMED) - SWELLING AND PAIN IN THE RIGHT PART OF THE LIPS THEN IN THE RIGHT PART OF THE FACE - PAIN/DISCOMFORT FROM SINUSES TO THE JAW THAT WENT DOWN TO THE NECK AND SHOULDER - DROOPING OF THE CORNER OF THE LIP - INTERMITTENT BULGING OF HER RIGHT EYE - DISCOLOURATION OF HER HANDS AND FEETS (RED/PURPLE) ACCOMPANIED WITH PARAESTHESIA (PINS AND NEEDLES SENSATION). ACCORDING TO THE PATIENT ANOTHER PRACTITIONER WAS CONSULTED AND INJECTED A FIRST COURSE OF HYALURONIDASE IN THE LIPS (ON (B)(6)). AFTER DISSOLVING, THE SYMPTOMS SEEMED TO CAME BACK DURING THE NIGHT (OF THE (B)(6)). SHE ALSO EXPERIENCED SWELLING IN THE HANDS. SHE RECEIVED 4 OTHER COURSES OF HYALURONIDASE FROM THE SAME PRACTITIONER (ON (B)(6)2024). AT THE BEGINNING OF (B)(6) THE PATIENT CONSULTED AGAIN HER INJECTOR, WHO ADVISED HER

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21166005 ↗
• InjuryDec 17, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THIS EVENT OCCURRED OUTSIDE THE USA, IN EUROPE (SPAIN). ON 25-NOV-2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.2ML OF RHA 4 IN THE NOSE USING AN UNSPECIFIED TECHNIQUE AND INJECTION ACCESSORY. ONE DAY AFTER THE INJECTION (ON (B)(6) 2024), THE PATIENT EXPERIENCED SWOLLEN AND RED NASAL TIP. THE INJECTOR PERFORMED A HYALURONIDASE INJECTION (150UI). ON (B)(6) 2024, THE LOCAL MEDICAL EXPERT ASSESSED A POTENTIAL VASCULAR COMPRESSION AND POSSIBLE SMALL INFECTION AND RECOMMENDED TO INJECT MORE HYALURONIDASE AND ADD ANTIBIOTICS (AUGMENTIN) + CORTICOIDS (IN DESCENDING REGIMEN) AND PROTON PUMP INHIBITORS (OMEPRAZOLE). CONSIDERING THE POTENTIAL VASCULAR COMPRESSION, THIS CASE WAS DEEMED REPORTABLE. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS OBTAINED BUT EVOLUTION OF SYMPTOMS ARE BEING MONITORED.

  Patient problems: Foreign Body Embolism

  MAUDE report 20953011 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED OUTSIDE THE USA, IN FRANCE. ON (B)(6)2024, THE SPANISH SUBSIDIARY NOTIFIED TEOXANE (B)(6) OF AN ADVERSE EVENT. A PATIENT WAS INJECTED ON (B)(6)2024 WITH A TOTAL OF 0,7ML OF RHA 3 IN THE LIPS (0,5ML IN THE UPPER LIP AND 0,2ML IN THE LOWER LIP) USING RETROGRADE INJECTION TECHNIQUE AND THE NEEDLE PROVIDED IN THE BOX (TSK 27G/13MM). THE DAY BEFORE THE INJECTION (ON (B)(6)2024), THE PATIENT HAD A DENTAL EXTRACTION. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A MODERATE INFLAMMATION ON THE UPPER LIP AFTER THE INJECTION (ON (B)(6)2024) REPORTED AS "SIMILAR TO AN ALLERGIC REACTION" AND VISITED THE EMERGENCY ROOM. SHE RECEIVED AN INTRAVENOUS ANTIHISTAMINE (POLARAMINE) AND LEFT WITH A PRESCRIPTION OF ORAL ANTIHISTAMINE (POLARAMINE 2MG, 3 TIMES PER DAY FOR 3 DAYS). CONSIDERING THE SEVERITY OF THE SYMPTOMS ASSESSED ON THE PICTURES RECEIVED, THIS CASE WAS CONSIDERED REPORTABLE. ON (B)(6)2024, THE LOCAL MEDICAL EXPERT WAS PUT IN CONTACT WITH THE INJECTOR WHO EXPLAINED THAT SYMPTOMS IMPROVED WITH ANTIHISTAMINE TREATMENT. ON (B)(6)2024, WE RECEIVED THE INFORMATION THAT THE SYMPTOMS IMPROVED FAVORABLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20819032 ↗
• 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 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 0.1 ML OF RHA 3 IN THE FOREHEAD USING A BOLUS TECHNIQUE AND THE NEEDLE SUPPLIED IN THE BOX. THE DAY OF THE INJECTION, A VASCULAR COMPROMISE WAS DIAGNOSED. THEREFORE, THE CASE WAS REPORTABLE. THE SAME DAY, 6000 UI (DOSE TO BE CONFIRMED) OF HYALURONIDASE WAS INJECTED, AND THE FOLLOWING TREATMENTS WERE PRESCRIBED: ASPIRINE (ADIRA 100) FOR 6 DAYS, GLUCOCORTICOIDS TREATMENT (DEXAMETASONA, 4MG) ONLY ONCE, SUN CREAM. ONE DAY AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT RECEIVED AN ANTIBIOTIC TREATMENT (MUPIROCINA), TWICE A DAY FOR 7 DAYS AND A NEW DOSE OF HYALURONIDASE (UNSPECIFIED AMOUNT). THE PATIENT HAS BEEN INJECTED IN LIPS IN 2020 WITH RESTYLANE KYSSE, AND IN 2021 AND 2022 IN LIPS WITH JUVEDERM WITHOUT ANY REACTION. THE PATIENT HAS A HISTORY OF ACNE AND WAS UNDER ANTI-ACNE TREATMENT (ISOTRETINOINA 60 MG), THE DAY OF THE INJECTION. A MEDICAL EXPERT CONTACTED THE INJECTOR. ACCORDING TO THE INFORMATION ON (B)(6) 2024 RECEIVED, THE SYMPTOMS ARE PARTIALLY RESOLVED.

  Patient problems: Foreign Body Embolism

  MAUDE report 20758556 ↗
• InjuryAug 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON (B)(6) 2024. THE PATIENT WAS INJECTED WITH RHA 3 IN THE NASOLABIAL FOLDS ON (B)(6) 2024. THE INJECTION WAS ADMINISTERED WITH AN UNSPECIFIED NEEDLE. TWO DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT EXHIBITED REDNESS AND A PUSTULE AROUND THE LEFT NASOLABIAL FOLD AT THE INJECTION SITE. AS A TREATMENT, THE INJECTOR PRESCRIBED AN ANTIBIOTIC (DOXYCYCLINE, 100 MG), AND AN UNKNOWN QUANTITY OF HYALURONIDASE WAS ADMINISTERED BY A DIFFERENT PROVIDER. ON (B)(6) 2024 WE WERE INFORMED THAT THE SYMPTOMS WERE RESOLVING. ACCORDING TO THE PATIENT'S MEDICAL HISTORY, SHE HAD A HISTORY OF ACNE AND HAS SUFFERED FROM BREAST CANCER. DUE TO THE LIMITED INFORMATION RECEIVED AND THE POTENTIAL SERIOUSNESS OF THE EVENTS ERPORTED, ON (B)(6) 2024, THETEOXANE'S MEDICAL EXPERT WAS CONTACTED TO PROVIDE A DIAGNOSIS. ACCORDING TO HIM, THE EVENTS REPORTED AND PICTURES WOULD BE COMPATIBLE WITH A VASCULAR OCCLUSION. THEREFORE, THE CASE WAS UPGRADED AS REPORTABLE TO THE FDA. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION IS AVAILABLE, BUT THE SITUATION AND SYMPTOMS REMAIN MONITORED.

  Patient problems: Foreign Body Embolism

  MAUDE report 19970663 ↗
• InjuryJun 28, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 30-MAY-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.5 SYRINGE OF RHA 3 IN THE LIPS. THE INJECTION WAS DONE WITH THE 27G NEEDLE. FOUR DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT REPORTED RIGHT-SIDED FACIAL NUMBNESS, SWELLING, BLURRED VISION, AND A HEADACHE. THE PATIENT WAS ON A FOLLOW-UP VISIT IN THE OFFICE AND VASCULAR OCCLUSION DIAGNOSIS WAS EXCLUDED. IT SEEMS THAT THE INJECTOR DIAGNOSED AN INFECTION DUE TO THE SWELLING BUT PRESCRIBED AN ANTIHISTAMINE DRUG (CETIRIZINE = ZYRTEC), AND A CORTICOSTEROID (MEDROL DOSE PACK, 4 MG), STARTING FROM (B)(6)2024, FOR SIX DAYS. HOWEVER, THE STEROID WAS ENDED ON (B)(6) 2024. DESPITE TREATMENT, THE PATIENT REPORTED ONGOING SYMPTOMS, THUS THE INJECTOR WANTES TO DISSOLVE THE FILLER WITH HYALURONIDASE (HYLENEX). BUT WHILE INJECTING THE PATIENT'S RIGHT FOREARM AS A PATCH TEST, THE PATIENT STARTED TO COMPLAIN ABOUT ARM DISCOMFORT AND HEAVINESS. THE INJECTOR ADVISED THE PATIENT TO GO TO THE ER FOR A CT SCAN, GIVEN BLURRED VISION AND A HEADACHE. THE HEAD CT WAS NEGATIVE. AS ADDITIONAL TREATMENT, THE PATIENT WAS PRESCRIBED AN ANTICONVULSANT DRUG, GABAPENTIN (NEURONTIN), DUE TO SUSPE

  Patient problems: Neuralgia; Skin Infection

  MAUDE report 19630992 ↗
• InjuryMay 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 02-MAY-2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.3 ML OF RHA 3 IN THE LIPS, USING A 30G NEEDLE.  DURING THE INJECTION, THE INJECTOR NOTICED IMMEDIATE BLANCHING AT THE INJECTION SITE, FOLLOWED BY A HEMATOMA TOWARDS THE MIDDLE OF THE LIP. THE PATIENT WAS TREATED WITH A WARM COMPRESS AND ACETYLSALICYLIC ACID (ASPIRIN). AS THE CAPILLARY REFILL WAS SLOW,  THE PATIENT WAS TREATED WITH 2.5 VIALS OF HYALURONIDASE (HYLENEX). THE DAY AFTER, ON (B)(6) 2024, THE PATIENT WAS TREATED WITH 9 ADDITIONAL VIALS OF HYALURONIDASE, APPLIED BILATERALLY ALONG WITH CONTINUED HEAT, MASSAGE, AND ASPIRIN. THE SAME DAY, THE CAPILLARY REFILL RETURNED TO NORMAL. ON (B)(6) 2024, THE SYMPTOMS HAD RESOLVED WITH ONLY SOME RETICULAR MARKINGS ON THE LIP AND A SORE INSIDE THE LIP IN THE MUCOSA REMAINING. THE SAME DAY, THE PATIENT BEGAN HYPERBARIC OXYGEN THERAPY. BASED ON THE INFORMATION RECEIVED, ALL THE SYMPTOMS SEEM TO POINT TO A VASCULAR OCCLUSION. THUS, THE CASE WAS ASSESSED AS REPORTABLE TO THE FDA.  ACCORDING TO THE RESOLUTION OF THE SYMPTOMS, THE CASE WAS CLOSED.

  Patient problems: Foreign Body Embolism

  MAUDE report 19403791 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE OCCURED 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 (RC 2404122) IN THE CHEEKBONES (HALF OF THE VIAL ON EACH SIDE), - ON (B)(6) 2023 WITH RHA 3 (CURRENT COMPLAINT) 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 (RC 2404122) IN THE MALAR AREA (0.6 ML ON EACH SIDE) 4 MONTHS AFTER THE LAST INJECTION, ON (B)(6) 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 CONTACTED TO PROVI

  Patient problems: Granuloma

  MAUDE report 19379522 ↗

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