MAUDE Adverse Event Report: TEOXANE SA RHA 4; HYALURONIC ACID DERMAL FILLER GEL

Lot Number	23152AL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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/cellulitis due to the localized heat, erythema and pain.On the same day, the patient was treated with antihistamine (chlorphenamine 4mg, as needed (prn) for 7 days) and antibiotics (clarithromycin 500mg, twice a day (bd) for 7 days).The oedema improved significantly with the antibiotics.On (b)(6) 2024, the patient was treated with hyaluronidase 1500 iu in 5mls saline.The oedema further reduced.On (b)(6) 2024, the patient was treated again with hyaluronidase 1500 iu in 5mls saline due to oedema still present at pre jowl sulcus and oral commissure.On (b)(6) 2024.The patient received 2 sessions of hyaluronidase and a great improvement of symptoms was observed.The injector felt, judging by the photos, that the patient had far too much filler injected, as her face looked very heavy as though overfilled, and possibly some inappropriate positioning of filler.Thus, this complaint was considered closed.
Additional Manufacturer Narrative
According to the information received, this case seems linked to a skin infection.Skin infections such as cellulitis, may manifest as inflammation, pain, skin warmth, oedema and erythema and appear within weeks after injection.These are well-known and widely documented adverse reactions in the context of hyaluronic acid filler injections.Infections are usually caused by an association of multiple bacteria that invade the wound at the site of injection due to a temporary disruption of the skin barrier.Lack of asepsis during injection and/or posttreatment care and intraoral injections are common etiologies for this complication.Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of rha 4.Overcorrections are well-known and documented incidents to hyaluronic acid filler injections.They are directly related to the injection technique and correspond to an excess of the injected product.Their resolution occurs over time through the natural dissolution of hyaluronic acid or by using hyaluronidase to induce dissolution.In addition, the risk of such reactions is mentioned in the instructions for use of rha 4.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: omar mounir ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 19936362
• Report Number: 3005975625-2024-00453
• Device Sequence Number: 4875801
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 010764017323270423152AL017250430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Lot Number: 23152AL0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female