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

Lot Number	TP27L-213715A0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/18/2023
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
On september 22, 2023, the spanish subsidiary notified us of an adverse event following the use of teosyal rha 3 in a patient.According to the information received, a patient was injected on (b)(6) 2023, with 2 ml of teosyal rha 3 in the nasolabial folds (1 ml per side).The injection was performed with a needle, using the multipuncture technique.On the same day, the patient experienced pain in the upper left lip.Two days later, on (b)(6) the patient experienced a burning sensation in the upper left lip and in the left malar area.The day after, on (b)(6) the patient presented with livedo reticularis and 2 small white areas in the upper left lip, the left malar area, and the lower left eyelid.The injector identified these symptoms as a vascular compromise and treated them accordingly.On (b)(6) he injected 600 iu of hyaluronidase in the nasolabial fold, and on (b)(6) he injected 1000 iu of hyaluronidase in the affected areas, causing a hematoma on the lower left eyelid.Additionally, the following treatment was prescribed: anticoagulant (clexane 40 mg), aspirin (adiro 300 mg), once a day, topical antibiotic (muporicin 2%).On (b)(6), one of our local medical experts contacted the injector.They decided to repeat the treatment on the same day, and then again on (b)(6) and (b)(6) 2023.On (b)(6) we were informed that the patient had recovered, without any further complication.Thus, this case is considered closed.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva 1201 ; SZ 1201
• Manufacturer (Section G): TEOXANE SA; rue de lyon 105; geneva, 1201 ; SZ 1201
• Manufacturer Contact: inés moreno pons ; rue de lyon 105; geneva, 1201 ; SZ 1201
• MDR Report Key: 17956336
• Report Number: 3005975625-2023-00696
• Device Sequence Number: 12082806
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 07640173230045
• 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): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Lot Number: TP27L-213715A0
• 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: 09/22/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2021
• 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
• Patient Age: 41 YR
• Patient Sex: Female