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

Lot Number	23121HL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	02/29/2024
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 rha 3.
Event or Problem Description
This case occured outside of the usa, in australia.The australian affiliate notified teoxane geneva of an adverse event on 05-mar-2024.A patient was injected with 1 ml of teosyal rha 3 in the oral commissures, into the lips, and the cutaneus lines on (b)(6) 2024.The injection was done with the microbolus technique, subdermally, using the needle provided in the box.Immediately after the injection, the injector noticed a blanching and decided to massage the area using a vibrata tool.The capillari refil was slow, and a bruise started to appear in the left top lip tubercle.  as treatment, 500 i.U.Of hyaluronidase were injected into the lip, and an immediate restoration of the capillari refil was observed.The injector chased the vessel to the top lip tubercle and lateral philtrum column, injecting anywhere duskiness or reticulation was present.At the time we received the initial information, the bruise on the lip had completely resolved.  on (b)(6) 2024, the injector confirmed the diagnosis that the patient presented a vascular occlusion.Thus, the case was assessed as reportable to the health authorities.According to the resolution of symptoms, this case was considered closed.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: omar mounir ; rue de lyon 105; geneva 1203 ; SZ 1203
• MDR Report Key: 18865180
• Report Number: 3005975625-2024-00162
• Device Sequence Number: 8238991
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 010764017323004510231
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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: 03/31/2025
• Device Lot Number: 23121HL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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 Sex: Female