MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	RHA® 2 (1mL)
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.Batch analyses undertaken confirm that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.
Event or Problem Description
A naturopath notified teoxane of an adverse event on (b)(6) 2023.A female patient was injected on (b)(6) 2023 with 1ml of teosyal rha 2 in the perioral areas, lips, and labial commissures.The injection was done with the needle provided in the box and a cannula.Three (3) days after, on (b)(6) 2023, the patient presented a series of signs and symptoms in and around the right upper lip (skin discolouration, redness, swelling, pain) that were caused by a vascular occlusion according to the local medical expert mandated on this case.This medical expert was also put in contact with the naturopath injector to provide treatment recommendations.They were the following: dissolve filler with hyaluronidase (2 ampoules at 150 iu), corticosteroids (brednesolon 50mg for 3-4 days), antibiotics (amoxiclav 2x1).The patient was also referred to her general practitioner.Based on information received on 14-jun-2023, the reporter in this case appears lost to follow-up.It is known that, as of (b)(6) 2023, the adverse event was partially resolved.

• Brand Name: TEOSYAL RHA 2
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: rue de lyon 105; geneva, geneva 1203
• MDR Report Key: 17245412
• Report Number: 3005975625-2023-00483
• Device Sequence Number: 6697906
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 07640173230021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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: 08/31/2024
• Device Model Number: RHA® 2 (1mL)
• Device Catalogue Number: 940007
• Device Lot Number: 22352AL0
• 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: 06/05/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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 Age: 53 YR
• Patient Sex: Female