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

Lot Number	22352AL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
Event or Problem Description
A german physician reported to teoxane an adverse event on (b)(6) 2023.A female patient was injected on (b)(6) 2023 with 1ml of teosyal rha 2 in the nasolabial folds and corners of the mouth.The injections were done with needles provided in the box using a retrotracing technique.The evening of (b)(6) 2023, an adverse reaction began in the area above the right upper lip, right nasolabial fold going upwards.The patient felt pain, limited sensitivity, difficulty to move the mouth, and presented a blue/pale colouration.Initial treatment included applying arnica salve and anti-inflammatory medication (ibuprofen).In the morning of (b)(6) 2023, the patient reaction became worse with more severe pain.The reaction appeared to be a vascular occlusion.The teoxane local medical expert was contacted by the physician injector; the former provided treatment recommendations but the injector was unable to treat the patient.Given the urgency of this case, teoxane gmbh commissioned a physician who is near the patient, who immediately treated her with: - (b)(6) 2023 - examination with ultrasound and hyaluronidase (1'200 iu), then prescription for aspirin (100), ibuprofen (400), and antibiotics (amoxiclav).- (b)(6) 2023 - hyaluronidase (900 iu) in the nose area.- (b)(6) 2023 - examination with ultrasound, no hyaluronidase injection, recommendation for antiseptic cream (bepanthen).On (b)(6) 2023, we received information that the patient had some discolouration of the skin, but was pain-free and recovering without sequelae foreseen.On (b)(6) 2023, the treating physician confirmed that the patient was well, with only some discolouration in the affected areas.The case was closed.

• 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: maria poujai ; rue de lyon, 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18179967
• Report Number: 3005975625-2023-00790
• Device Sequence Number: 15426167
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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 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: 10/26/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 44 YR
• Patient Sex: Female