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

Lot Number	22482JL0
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vasovagal syncope 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.Of note, rha 4 is not indicated for use in the mid-face area in the us.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 07-oct-2024.A male patient was injected on (b)(6) 2024 with 0.2 ml of rha 4 in the midface.The injection was done with unspecified needle.(gauge size: 27).Following the injection, the patient experienced a vasovagal syncope.The patient recovered and regained consciousness within minutes.Based on the information received, a vasovagal syncope due to teoxane product injection could not be ruled out.Thus, the case was assessed as reportable to the fda.Despite several reminders, no additional information could be received.Thus, the complaint was closed as is.No further information was received at this stage.Further attempts will be made to obtain additional information.
Additional Manufacturer Narrative
Vasovagal syncope 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.Of note, rha 4 is not indicated for use in the mid-face area in the us.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on (b)(6)2024.A male patient was injected on (b)(6)2024 with 0.2 ml of rha 4 in the midface.The injection was done with an unspecified needle (gauge size: 27).Following the injection, the patient experienced a vasovagal syncope.The patient recovered and regained consciousness within minutes.Based on the information received, a vasovagal syncope due to teoxane product injection could not be ruled out.Thus, the case was assessed as reportable to the fda.Despite reminders no further information could be retrieved.Based on the resolution of the symptoms, the case was closed.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: izabela bat ; SZ
• MDR Report Key: 20618812
• Report Number: 3005975625-2024-00598
• Device Sequence Number: 8874108
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 7640173232704
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 12/03/2024
• Device Lot Number: 22482JL0
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male