MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3; DERMAL FILLER

Model Number NOT APPLICABLE

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

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling/ Edema (4577)

Event Date 11/16/2021

Event Type  Injury  

Event Description

According to the information received on 17 nov 2021, a patient was injected in the nose on (b)(6) 2021 with a teosyal rha 3 (tp27l-211127b1) product.Immediately after the tip nose treatment, a bleach appeared in the nose wing and in the columella.The patient complained of pain and pressure in the nose and after few minutes a purple discoloration appeared in the nose tip and in a nose¿s wing.For this reason, the doctor immediately injected 150 units of hyaluronidase and another 500 units after 5 hours.Then, the bleaching disappeared and the purple discoloration decreased.On (b)(6) 2021, the patient received 100 units of hyaluronidase.The bleaching and the marbled was resolved, but the nose of the patient was very swollen.Antibiotic, corticosteroids and nitroglycerin paste were prescribed to the patient.A medical expert of the local affiliate (dr (b)(6)) was contacted in order to help in the management of the case who advised to prescribed antiedemigen.According to the latest information received on 23 nov 2021, the adverse event is resolving.Based on the chronology of the symptoms, the photographs showing the patient¿s symptoms, and the positive evolution of the symptoms thanks to the hyaluronidase, this case might be linked to a vascular skin disorder.As precaution, this case was therefore assessed as reportable.

Manufacturer Narrative

Additional mfr narrative: batch number of the related product has been retrieved and quality investigations performed.The batch has been released in accordance with the manufacturers' specifications.1 other complaint, (b)(4) has been registered to date for this batch number.(b)(4) includes 2 technical issues in poland, product leakage between the luer lock and needle and high injection pressure which are not related to the present complaint.Corrected data: a local medical expert has been contacted to manage the situation.According to the received investigation, this case seems related to a vascular complication in the injected area, which is a well-known adverse reactions.The vascular complication is 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.Batch analyse undertaken confirms that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.

• Brand Name: TEOSYAL RHA 3
• Type of Device: DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer Contact: nicolas caill ; rue de lyon; 105; geneva 1203 ; CH 1203 ; 022344-963
• MDR Report Key: 12951309
• MDR Text Key: 283767015
• Report Number: 3005975625-2021-00701
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-211127B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• 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 Sex: Female