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

Lot Number TPUL-23112CL0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Embolism/Embolus (4438); Foreign Body Embolism (4439)

Event Date 02/09/2024

Event Type  Injury  

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 Description

This case occured outside the usa, in chile.On (b)(6) 2024, the chile distributor notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with teosyal rha 4 in the nose for a rhinomodeling procedure (0.2 ml in the nasal base, 0.1ml in the columella, 0.1ml in the nasal bridge, 0.1ml in the nasal dorsum, 0.2 ml in the nose tip (0.1 ml each sides)).In order to inject hyaluronic acid, the injector used a cannula.Just after the injection on the nose tip, when the cannula was removed, the patient presented with an alteration of the color of the skin, becoming slightly pale, indicating vascular occlusion.Immediately the doctor began to massage the area in order to improve the circulation.However, the skin was becoming cyanotic and the patient was losing sensitivity.In addition, the injector tried to drain the blood and some hyaluronic acid that was coming out of the tip pertuite.He/she enlarged the hole made for the cannula with a 18g needle to expel as much hyaluronic acid as possible.The injector injected hyaluronidase, and continued with a 32g needle to flood the entire nose and between the eyebrows (that was seen with impaired circulation).An alteration of skin color, temperature and absence of sensitivity were observed.The following treatment was prescribed on (b)(6) 2024 : - warm compresses.- steroids anti-inflammatory (prednisone 20 mg 12/12h for 3 days).- steroids cream (postec (betamethasone + hyaluronidase) recommended to be applied every 2 hours with soft massages.The patient was discharged with orientation to return to the office in the afternoon the same day for a new evaluation.During the evaluation, the patient already looked better but still with residual suffering.She received a new round of hyaluronidase injections (3,000 utr), the injector flooded the area, applied postec cream and massaged.The sensitivity was still affected but there was an improvement of skin oxygenation and discreet alteration of temperature.On (b)(6) 2024, the patient received several micropunctures with a 32 g needle, three sessions of hyaluronidase injections and a session of hyperbaric chamber 100% oxygen (session of 60 minutes) that had to be done for 5 days in a row.She also received injections of recombinant enzymes ((b)(6)).Patient's sensitivity was recovered.According to the positive recovery of the patient and to the medical support provided by the injector, the complaint was considered closed.

• Brand Name: RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: juliette vrangos ; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• MDR Report Key: 18854501
• MDR Text Key: 337069912
• Report Number: 3005975625-2024-00099
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023112CL017250331
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: TPUL-23112CL0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male