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

Lot Number	TPUL-22441IL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Skin Inflammation/ Irritation (4545)
Date of Event	08/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside the us, in united kingdom.On 30-aug-2023, an injector from united kingdom notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2023 with 1.2ml of teosyal rha 4 in the marionette lines and in the chin (bolus and fanning technique).Around 6 weeks after the injections, on (b)(6) 2023, the patient presented with swelling and solid filler in the marionette lines (both sides), without pain or heat.The patient received as treatment : hyaluronidase injections : 1500iu on (b)(6) 2023, 1500 iu on (b)(6) 2023 and 1500iu on (b)(6) 2023.Antibiotics (clarithromycin 500mg and ciprofloxacin 500mg) on (b)(6) 2023.According to the injector, the patient seemed to be responding well to hyaluronidase.Then, another adverse reaction appeared after the third session and the injector suspected a cellulitis.Additionally, the local medical expert was put in contact with the practitioner to advice on this case.According to the follow up information received on 26-sep-2023, the patient had been treated for cellulitis and the injector reached out to the medical expert for further advice.Despite several reminders, no information was provided on the resolution of symptoms, and we have been informed that we will not receive any further information.Therefore, the patient was considered lost to follow up and the complaint was closed.
Additional Manufacturer Narrative
Skin infections such as cellulitis, may manifest as swelling, hardening, 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 teosyal products.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: same as contact office ; SZ
• MDR Report Key: 17842917
• Report Number: 3005975625-2023-00642
• Device Sequence Number: 7173818
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 01076401732300691022441IL017241130
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/29/2023

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: 11/30/2024
• Device Lot Number: TPUL-22441IL0
• 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: 08/30/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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 Age: 53 YR
• Patient Sex: Female