RHA® Redensity RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2 (REF 940056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640173231653), received between Jul 10, 2023 and Aug 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMEVIGILANCE 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 (CURRENT COMPLAINT). 1.2 ML OF RHA 4 IN THE CHEEKBONE. THE INJECTION WAS DONE WITH A 27G NEEDLE (LINKED COMPLAINT: (B)(4). 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 (B)(6)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 EXCLUD

  Patient problems: Dyspnea

  MAUDE report 19947220 ↗
• InjuryAug 1, 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 03-JUL-2024. A PATIENT WAS INJECTED WITH RHA REDENSITY INTO THE FOREHEAD ON (B)(6) 2024. THE INJECTION WAS ADMINISTERED VERY SUPERFICIALLY USING AN UNSPECIFIED NEEDLE. TWO DAYS AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT DEVELOPED REDNESS, WITH BLISTERS AND WHITEHEADS ON THE FOREHEAD. THE FOLLOWING DAY, ON (B)(6) 2024, THE REDNESS APPEARED TO DARKEN. THE INJECTOR SUGGESTED THE POSSIBILITY OF VASCULAR OCCLUSION AND INJECTED HYALURONIDASE (HYLENEX) AS A TREATMENT. DESPITE REMINDERS, NO UPDATES WERE PROVIDED ABOUT THE PATIENT, THUS THE CASE WAS CLOSED AS IS.

  Patient problems: Embolism/Embolus; Foreign Body Embolism

  MAUDE report 19879957 ↗
• InjuryMay 16, 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 (B)(6) 2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH A TOTAL OF 2 ML OF RHA REDENSITY IN THE MARIONETTE LINES (0.25 ML ON EACH SIDE), CHIN (0.5 ML), AND TEAR TROUGH (1 ML). THE INJECTIONS WERE DONE WITH A 25G CANNULA.  DURING THE INJECTION, THE SKIN AROUND THE RIGHT MARIONETTE BLANCHED. THE AREA WAS MASSAGED, AND THE CAPILLARY REFILL WAS CHECKED AND WAS SLOW (TAKING 2-3 SECONDS). THE PATIENT DID NOT REPORT PAIN IN THE AREA BUT WAS UNDER CONSTANT MEDICAL OBSERVATION UNTIL THE CAPILLARY REFILL RETURNED TO NORMAL. AFTER THE PATIENT LEFT THE CLINIC, THE INJECTOR CONTINUED TO CLOSELY FOLLOW-UP WITH THE PATIENT WITH PHOTOS AND VIDEOS. IN THE EVENING, THE PATIENT PRESENTED WITH MOTTLING AND DELAYED CAPILLARY REFILL AND IMMEDIATELY WENT BACK TO THE CLINIC TO BE TREATED WITH 900 I.U. OF HYALURONIDASE (HYLENEX). THE EVENT WAS DIAGNOSED AS A VASCULAR OCCLUSION OF MODERATE INTENSITY. ON (B)(6) 2024, THE CAPILLARY REFILL RETURNED TO NORMAL LIMITS, BUT THE AFFECTED AREA WAS STILL LOOKING MOTTLED. THUS, UNTIL (B)(6) 2024, THE INJECTOR CONTINUED TO TREAT THE PATIENT WITH HYALURONIDASE (A TOTAL OF 4700 UNITS IN THREE DAYS).  IN ADDITION, T

  Patient problems: Foreign Body Embolism

  MAUDE report 19330071 ↗
• InjuryApr 26, 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 (B)(6) 2024. THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH 1 ML OF RHA REDENSITY IN THE LIPS. THE INJECTION WAS DONE WITH A CANNULA USING THE RETROTRACING TECHNIQUE. BEFORE THE PROCEDURE, THE PATIENT RECEIVED LIDOCAINE AND AN EPINEPHRINE INJECTION NEAR TO THE ORAL COMMISSURES.  THE MEDICAL HISTORY OF THE PATIENT MENTIONED HYPOTHYROIDISM AND SEVERAL MEDICATIONS: LEVOTHYROXINE (SYNTHROID) AND PLEXUS IN ADDITION TO MULTIVITAMINS, VITAMIN C, AND VITAMIN D FIVE MINUTES AFTER THE INJECTION, ON (B)(6) 2024, THE INJECTOR NOTICED THAT LIPS STARTED TURNING PALE AND CAPILLARY REFILL SLOWED. THE PATIENT FELT ''NUMB''. A VASCULAR OCCLUSION WAS DIAGNOSED. THE PATIENT WAS UNDER OBSERVATION FOR 1.5 HOURS. DURING THIS TIME, AS A TREATMENT, THE INJECTOR USED 1 ML OF HYALURONIDASE (HYLENEX) ON THE LEFT SIDE OF THE PERIORAL AREA VIA CANNULA AND GAVE A WARM COMPRESS. AFTER THAT, THE AFFECTED AREA AND CAPILLARY REFILL IMPROVED. THE INJECTOR MASSAGED THE AFFECTED AREA, AND THEN THE AREA BECAME WHITE AGAIN, BUT THE CAPILLARY REFILL WAS GOOD. AN ADDITIONAL 0.5 ML OF HYALURONIDASE (HYLENEX) WAS USED, AND THE LIPS RETURNED TO THEIR PINK COLOR. AROUND 1.5

  Patient problems: Foreign Body Embolism

  MAUDE report 19189303 ↗
• InjuryJul 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS OCCURRED OUTSIDE OF THE USA, IN GERMANY. A NATUROPATH INJECTOR NOTIFIED TEOXANE OF AN ADVERSE EVENT ON (B)(6) 2023. A FEMALE PATIENT WAS INJECTED ON (B)(6) 2023 AT ABOUT 18:30 WITH 0.3 ML OF RHA REDENSITY, SUPERFICIALLY INTO ACNE SCARS ON THE LEFT SIDE OF THE CHIN. IMMEDIATELY AFTER THE INJECTION, THE PATIENT PRESENTED A CHANGE IN SKIN COLOUR DESCRIBED AS "BLUE" AND A "TYPICAL LIVID DISCOLORATION". THE INJECTOR RECOGNIZED AN EMBOLISM AND IMMEDIATELY TREATED THE AREA WITH HYALURONIDASE (1500 IU). THE NEXT MORNING, ON (B)(6) 2023, THE REACTION PROGRESSED TO "CLEAR REDDISH-BLUE PAINFUL MUCOSAL LESION" AND BLISTERS THAT LOOK LIKE "THREE MINI PIMPLES" ON THE INSIDE OF THE LIP MUCOSA. THE INJECTOR TREATED WITH ANOTHER ROUND OF HYALURONIDASE (1500 IU). AS OF (B)(6) 2023, THE ADVERSE REACTION WAS PARTIALLY RESOLVED. DESPITE REMINDERS, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Embolism

  MAUDE report 17287560 ↗