MAUDE Adverse Event Report: TEOXANE SA RHA4; RESILIENT HYALURONIC ACID

Model Number	RHA® 4 (1mL)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In order to conduct a product-related investigation; including review of the batch and its complaint history, the batch number of the concerned product was requested.Cellulitis is well-known and documented adverse reaction in the context of hyaluronic acid filler injections.It is typically caused due to common pathogens present on the skin.Cellulitis is almost always caused by ss-hemolytic streptococci and consists of an acute spreading inflammation of large areas of skin and subcutaneous tissues.Clinical findings include local pain, tenderness, swelling whereas systematic features include fever, chills, malaise and lymphangitis, and/or bacteremia.Mild forms can be treated with oral antibiotics, while more serious cases require intravenous antibiotics.Additionally, the risk of such adverse event is also mentioned in the instructions for use of teosyal products.
Event or Problem Description
According to the information received on feb.14, 2023, a patient was injected in the end of jan.2023 (unspecified date) with 0.4 ml of rha 4 into the bilateral cheeks.Approximately 3 weeks post-injection, the patient experienced soreness and swelling, accompanied by tenderness all over injected area.The emergence of a possible cellulitis was suspected by the practitioner.Therefore, on feb.13, 2023, as a corrective action, an antibiotic treatment (cefalexin; keflex) was prescribed.Following this initial report, a local medical expert was mandated to provide the clinical assessment and advice on this case.As per the medical expert notes, the emergence of cellulitis is rather related to the procedure including the exposure of the skin to different pathogens, however, this could also be related to the secondary infection due to injection site inflammation associated with dermal filler treatment.Therefore, based on the characteristic of this event, the case has considered to be reportable.No additional information is available at the time of this report.The patient's situation, and symptom's evolution are monitored.
Additional Manufacturer Narrative
Cellulitis is well-known and documented adverse reaction in the context of hyaluronic acid filler injections.It is typically caused due to common pathogens present on the skin.Cellulitis is almost always caused by ss-hemolytic streptococci and consists of an acute spreading inflammation of large areas of skin and subcutaneous tissues.Clinical findings include local pain, tenderness, swelling whereas systematic features include fever, chills, malaise and lymphangitis, and/or bacteremia.Mild forms can be treated with oral antibiotics, while more serious cases require intravenous antibiotics.Additionally, the risk of such adverse event is also mentioned in the instructions for use of teosyal products.
Event or Problem Description
According to the information received on feb.14, 2023, a patient was injected in the end of (b)(6) 2023 (unspecified date) with 0.4 ml of rha 4 into the bilateral cheeks.Approximately 3 weeks post-injection, the patient experienced soreness and swelling, accompanied by tenderness all over injected area.The emergence of a possible cellulitis was suspected by the practitioner.Therefore, on (b)(6) 2023, as a corrective action, an antibiotic treatment (cefalexin; keflex) was prescribed.Following this initial report, a local medical expert was mandated to provide the clinical assessment and advice on this case.As per the medical expert notes, the emergence of cellulitis is rather related to the procedure including the exposure of the skin to different pathogens, however, this could also be related to the secondary infection due to injection site inflammation associated with dermal filler treatment.Therefore, based on the characteristic of this event, the case was considered to be reportable.No additional information is available at the time of this report.The patient's situation, and symptom's evolution are monitored.

• Brand Name: RHA4
• Common Device Name: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE SA; 105 rue de lyon; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ornella fauconnot ; 105 rue de lyon; geneva, ; SZ
• MDR Report Key: 16529704
• Report Number: 3005975625-2023-00133
• Device Sequence Number: 19494371
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 07640173230069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Model Number: RHA® 4 (1mL)
• Device Catalogue Number: 940009
• Device Lot Number: TPUL- 22122IA0;TPUL- 22242KL0
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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