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

Lot Number	TPUL-22492FL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On november 14, 2023, the spanish subsidiary notified us of an adverse event following the use of teosyal rha 4 in a patient.A patient was injected on (b)(6) 2023, with 0.5 ml of teosyal rha 4 in the right cheek.The injection was done with a cannula using the retrotracing technique.According to the medical history of the patient, she was injected with teosyal rha 4 in 2018 in the zygomatic area and the nasolabial folds, without presenting with any adverse reactions.Immediately after the injection, on (b)(6) 2023, the patient experienced a mild vascular compromise, as she presented with delayed capillary refill in the injected area.On the same day, the injector administered 3 cycles of hyaluronidase (2000 iu in total) to the patient in one hour and a half.On november 14, 2023, we were informed that the patient had completely recovered.Thus, this case was considered closed.
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.

• Brand Name: RHA 4
• 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
• Manufacturer Contact: inés moreno pons ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18236089
• Report Number: 3005975625-2023-00846
• Device Sequence Number: 13097762
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 07640173232704
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: 12/31/2024
• Device Lot Number: TPUL-22492FL0
• 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: 11/14/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2022
• 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: 46 YR
• Patient Sex: Female