MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER

Lot Number	TP30L-23271CL0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Localized allergic reactions that may manifest as strong oedema within minutes to hours are well-known and documented adverse reactions to hyaluronic acid filler injections.They are immune-mediated reactions related to patient conditions such as allergies to ha, lidocaine, or nickel composing the needle.With medical treatment, symptoms can be fully resolved quickly and without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of rha 2 products.However, in this case the injector applied anesthetic cream before the injection and according to the medical expert.The patient could have reacted to one of the excipients of this cream.
Event or Problem Description
The italian subsidiary notified teoxane geneva of an adverse event on 19-apr-2024.A patient was injected on (b)(6) 2024 with teosyal rha 2 in the lips (0.25 ml in the lower lip and 0.25 ml in the upper lip).The injection was done with the vertical technique using the needle provided in the box.Before the injection, the patient received anesthetic cream.Immediately after the injection, the patient experienced a strong oedema in the lips.The same day, the injector prescribed corticoids (bentelan 4 mg), but the oedema persisted.Therefore, with the support of the local medical expert, the patient was treated with an intramuscular injection of cortisoids (bendelan) and antihistamines (trimeton).After the treatment, the symptoms improved.  from (b)(6) 2024, the patient started to take corticoid (deltacorten 25mg 1 tbt a day) as adviced by the local medical expert.The patient has a history of filler injections with teoxane products without any issues.According to the injector, the patient would have reacted to the lidocain in the filler.However, the local medical expert though that the patient rather reacted to one of the excipients of the anesthetic cream.

• Brand Name: RHA 2
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: morgane burgisser
• MDR Report Key: 19339875
• Report Number: 3005975625-2024-00286
• Device Sequence Number: 7069997
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 01076401732300211023271CL017250731
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 07/31/2025
• Device Lot Number: TP30L-23271CL0
• 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: 04/19/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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