MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number RHA® 2 (1ML)

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Foreign Body Embolism (4439)

Event Date 11/18/2021

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 case occurred in the united states.According to the information received on 24-nov-2021, a patient was injected on (b)(6) 2021 with a rha 2 product to the forehead.On an unknown exact date, between (b)(6) 2021, the patient presented with a vascular occlusion.Additionally, the physician noticed black and pink discoloration as well as some blistered looking tissue, from the middle third of her forehead going up to the hairline.As corrective treatments, the patient received antibiotics and steroids.At the time of this report, the events remained on going and no additional information was available.

Event Description

This case occurred in the united states.According to the information received on 24-nov-2021, a patient was injected on (b)(6) 2021 with a rha 2 product to the forehead.On an unknown exact date, between (b)(6) 2021 and 21-nov-2021, the patient presented with a vascular occlusion.Additionally, the physician noticed black and pink discoloration as well as some blistered looking tissue, from the middle third of her forehead going up to the hairline.As corrective treatments, the patient received antibiotics and steroids.As corrective treatments, the patient received antibiotics and steroids.Despite several attempts to follow up, no further information could be obtained.

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.

• Brand Name: TEOSYAL RHA 2
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TEOXANE SA; 105 rue de lyon; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ornella fauconnot ; 105 rue de lyon; geneva, 1203 ; SZ 1203
• MDR Report Key: 13078064
• MDR Text Key: 284705243
• Report Number: 3005975625-2021-00714
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 07640173230021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RHA® 2 (1ML)
• Device Catalogue Number: 940007
• Device Lot Number: TP30L-210916B0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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
• Patient Sex: Female