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

Lot Number TP27L-202323B

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

Patient Problems Pain (1994); Unspecified Vascular Problem (4441); Swelling/ Edema (4577)

Event Date 11/30/2020

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 sequelae.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 the received information, the patient was injected with a teosyal rha 3 product (tp27l-192323b) on (b)(6) 2020 in the lips and in the marionette lines.On (b)(6) 2020 the patient experienced symptoms of vascular compromise in the lower lip.She complained of hematoma, pain and swelling localized in the lower lip the practitioner injected 900 ui of hyaluronidase in the affected area on (b)(6) and prescribed drug therapy with: antibiotic (augmentin) for 7 days, oral cortisone (bentelan) for 3 days, fucidin cream to apply to the affected area.According to the latest received information the symptoms completely resolved.

• 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: 11036249
• MDR Text Key: 222293387
• Report Number: 3005975625-2020-00042
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Lot Number: TP27L-202323B
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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