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

Model Number	RHA® 2 (1ML)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005975625-2021-00714
• Device Sequence Number: 14948513
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 07640173230021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female