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

Lot Number TP27L-194811B

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Vascular System (Circulation), Impaired (2572)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Informations received to this date points out vascular compromise ont hte injected area 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.Literature data: de boulle k, heydenrych i.Patient factors influencing dermal filler complications: prevention, assessment, and treatment.Clin cosmet investig dermatol.2015;8:205-14.Signorini, m., et al.(2016)."global aesthetics consensus: avoidance and management of complications from hyaluronic acid fillers-evidence- and opinion-based review and consensus recommendations." plastic and reconstructive surgery 137(6): 961e-971e.Delorenzi, c.(2014)."complications of injectable fillers, part 2: vascular complications." aesthetic surgery journal / the american society for aesthetic plastic surgery 34(4): 584-600.

Event Description

The present incident happened outside the us, in (b)(6).According to the received information, one day after the injection of teosyal rha 3 in the lips, the patient experienced symptoms of arteria occlusion of the injected area.It is reported that the upper lip hurts and is darkly discolored.The patient was treated with hyaluronidase 1ml (1500u) on (b)(6).17:30.The area of injection became lighter after injection with hyaluronidase.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC ACID DERMALL 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 contact office
• Manufacturer Contact: fiona di folco ; rue de lyon 105; geneva, CH120-3 ; SZ CH1203
• MDR Report Key: 10232624
• MDR Text Key: 197924630
• Report Number: 3005975625-2020-00017
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Lot Number: TP27L-194811B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• 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