MAUDE Adverse Event Report: TEOXANE SA RHA 3 MEPI; HYALURONIC ACID DERMAL FILLER GEL

Lot Number	25212GL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vasovagal syncope (or presyncope) is a rare but well-known adverse reaction to hyaluronic acid filler injections or any other type of injection.It generally occurs as a body reaction to stress, which, in the context of dermal filler treatment, could be triggered by a phobia of needles, anxiety about the treatment, fear of blood, or pain.It generally lasts a few seconds and resolves spontaneously without sequelae.In this case, the concomitant medication for the treatment of hypertension may constitute an alternative etiology for the onset of the event.Of note, rha 3 is not indicated for the midface in the usa this is default text configured for block h10.
Event or Problem Description
Vasovagal events/vasovagal syncope/lost consciousness for a few seconds [syncope] ([hypotension]) rha 3 in the midface [off label use].Case narrative: on 23-mar-2026, primevigilance notified teoxane geneva of an adverse event from the united states.According to the information received from the injector, a male patient was injected on (b)(6) 2026 with 1 ml rha 3 in the midface with a cannula.The patient's history included botulinum toxin (botox) in an unknown date in frontalis, glabella, and crow's feet and hypertension with no adverse event reported.The patient's concomitant medication included amlodipine and telmisartan/hydrochlorothiazide for hypertension.On (b)(6) 2026, on the same day, the patient experienced two vasovagal syncope episodes which occured after completion of the treatment and during which the patient lost consciousness for a few seconds.Between the two episodes the patient returned to baseline.Once consciousness was restored the patient was placed in trendelenburg position, and received cold packs, oral fluids and a granola bar.The blood pressure was measured after the second episode at 87/47 mmhg and returned to baseline allowing the patient to leave the practice.The intensity of the events of syncope and low blood pressure was moderate.The injector evaluated the symptoms likely related to the injection procedure.The outcome of the events was resolved.Despite several reminders, no further information could be retrieved.The complaint was considered closed.Imdrf code annex g is erroneous is this case (due to database issue).Please consider code g04127 ¿ syringe.

• Brand Name: RHA 3 MEPI
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva 1203 ; SZ 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon 105; geneva 1203 ; SZ 1203
• MDR Report Key: 24937663
• Report Number: 3005975625-2026-00024
• Device Sequence Number: 5180239
• Product Code: LMH
• UDI-Device Identifier: 07640173236177
• UDI-Public: (01)07640173236177(10)25212GLL(17)270523
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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 Lot Number: 25212GL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male