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

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/20/2019

Event Type  Injury  

Manufacturer Narrative

Vascular complications (occlusions) are well known and documented adverse reactions as part of hyaluronic acid-based dermal fillers injections.They are related to the accidental injection of the product inside or close to a blood vessel leading to an occlusion or a compression and blocking the blood flow, generally refered to as vascular complication.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of vascular complication and skin necrosis are mentioned in the product labelling.Please refer to the literature data below.Literature data: delorenzi c.Complications of injectable fillers, part 2: vascular complications.Aesthet surg j.2014;34(4):584-600.Funt d, pavicic t.Dermal fillers in aesthetics: an overview of adverse events and treatment approaches.Clin cosmet investig dermatol 2013;6:295-316.Manafi a, barikbin b, manafi a, hamedi zs, moghadam sa.Nasal alar necrosis following hyaluronic acid injection into nasolabial folds: a case report.World journal of plastic surgery.2015;4(1).Hong, j.Y., et al., impending skin necrosis after dermal filler injection: a "golden time" for first-aid intervention.Dermatol ther, 2017.30(2).Maruyama, s., a histopathologic diagnosis of vascular occlusion after injection of hyaluronic acid filler: findings of intravascular foreign body and skin necrosis.Aesthet surg j, 2017.37(9): p.Np102-np108.Salval, a., et al., impending facial skin necrosis and ocular involvement after dermal filler injection: a case report.Aesthetic plast surg, 2017.41(5): p.1198-1201.Wang, q., et al., vascular complications after chin augmentation using hyaluronic acid.Aesthetic plast surg, 2018.42(2): p.553-559.

Event Description

The present event happened outside of the u.S., in (b)(6).According to the received information, after being injected in the lips a few days ago, the patient presented with a severe adverse reaction, likely to ba a vascular compromise in the upper lip area.According to the received information, the injector monitored the situation over the weekend, and saw her on (b)(6) 2019.During this visit, the injector constated that the symptoms were in line with a vascular occlusion, and did a patch test and injected hyalase 1500 iu in several sites of the area, especially under the vessel that was damaged.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC ACID DERML FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as conatct office
• Manufacturer Contact: nicolas caill ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 9664015
• MDR Text Key: 190035656
• Report Number: 3005975625-2020-00005
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-191321B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2019
• 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