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

Lot Number TPUL-210525A0

Device Problem Output Problem (3005)

Patient Problem Granuloma (1876)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

Granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.A treatment with hyaluronidase and anti-inflammatories generally allows to treat these reactions quickly and effectively, although certain granulomas at an advanced stage might be unresponsive to hyaluronidase.The risk of such reaction is mentioned in the instructions for use of teosyal products.

Event Description

This case occured outside of the us, in (b)(6).According to the information received on 5 jan 2022, a patient was injected on (b)(6) 2021 in the jawline area with a teosyal rha 4 (tpul-210525a0) product and a teosyal puresense ultra deep product (complaint (b)(6)).On (b)(6) 2021, the patient developed a left monolateral tumefaction as big as a mandarin, which was reported as mobile and painless.On (b)(6) 2022, the patient performed an ultrasound, which showed the presence of hyaluronic acid (5x4.5 cm) with a thickness of 1 cm, with mild vascularization and likely traceable to a granulation/fibrotic tissue.The injector tried to aspire the product with a needle, without improvement, and injected 150 units of hyaluronidase but no improvement was observed neither.On (b)(6) 2022, a medical expert was contacted in order to help in the management of this case.According to him, the tumefaction was likely a granuloma and recommended a mri to confirm the exact location and the importance of this mass.He also advised to inject hyaluronidase again in higher dose, 1500 iu, possibly repeating it at one week.The injector planed to follow up with the patient in a couple of weeks.On (b)(6) 2022, we were informed that the patient received 300 u.I of hyaluronidase on an unknown date.Furthermore, on 27 jan 2022, we were informed that the injector could not perform a mri yet.Despite several reminders, no additional information was received at the time of this report.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ornella rousseaux ; rue de lyon, 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 13452658
• MDR Text Key: 285155468
• Report Number: 3005975625-2022-00012
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: TPUL-210525A0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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