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

Model Number NOT APPLICABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Necrosis (1971); Unspecified Vascular Problem (4441)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.

Event Description

This event happened outside of the us, in (b)(6).According to information received as of (b)(6) 2021, a female patient was injected with 1.2 ml of teosyal puresense ultra deep (tsul-211712b0) into the bilateral mid-cheeks, along with 0.6 ml of teosyal puresense redensity 2 (tsrl-211225c0) into the bilateral lower eyelids, and with 1.2 ml of teosyal rha 4 (tpul-211811b0) into the nasolabial folds, oral commissures areas on (b)(6) 2021 (object of this complaint).Following injection, on the same day, the patient experienced skin discoloration and pain on the left nasal area.Two days post-injection, on (b)(6) 2021 the small vesicles and papules appeared in the same area.We were informed that the patient had reported the adverse events to a dermatology service, 4 days post-injection on (b)(6) 2021, where they suspected either the arterial occlusion, herpes, or bacterial infection.Accordingly, a serological infection analysis was performed.On (b)(6) 2021 the (b)(4) subsidiary contacted a local medical expert to monitor the situation and provide treatment advice.The medical expert was informed that on (b)(6) 2021 the patient received a curettage treatment to remove the necrotic tissue, accompanied by 15 iu of hyaluronidase injection.The medical expert recommended to follow the patient on the same day, and in case the vesicles were still presented another dose of hyaluronidase (500 iu) would be considered along with another curettage treatment.On (b)(6) 2021 we were informed that serological infection analysis was negative, and as a corrective action the patient received an antibiotic treatment, accompanied by an anti-inflammatory agent (corticosteroids) with 2 sessions of 500 iu hyaluronidase injection.Plus, the patient's symptoms were resolving properly.All areas with lesions healed well, only a few areas with erythema were presented on the nose.Furthermore, in a month an intense pulsed light (ipl) therapy would be considered as an additional treatment to the patient.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMALL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, CH120 3; SZ CH1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as contact office
• Manufacturer Contact: fiona di folco ; rue de lyon 105; geneva, CH120-3 ; SZ CH1203
• MDR Report Key: 12539449
• MDR Text Key: 273538682
• Report Number: 3005975625-2021-00552
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-211811B
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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 Age: 48 YR