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

Model Number	RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This occurred outside of the usa, in germany.A naturopath injector notified teoxane of an adverse event on (b)(6) 2023.A female patient was injected on (b)(6) 2023 at about 18:30 with 0.3 ml of rha redensity, superficially into acne scars on the left side of the chin.Immediately after the injection, the patient presented a change in skin colour described as "blue" and a "typical livid discoloration".The injector recognized an embolism and immediately treated the area with hyaluronidase (1500 iu).The next morning, on (b)(6) 2023, the reaction progressed to "clear reddish-blue painful mucosal lesion" and blisters that look like "three mini pimples" on the inside of the lip mucosa.The injector treated with another round of hyaluronidase (1500 iu).As of (b)(6) 2023, the adverse reaction was partially resolved.Despite reminders, no further information was provided.
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 sequalae.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 teoxane dermal filler products.

• Brand Name: RHA REDENSITY
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: rue de lyon 105; geneva, geneva 1203
• MDR Report Key: 17287560
• Report Number: 3005975625-2023-00495
• Device Sequence Number: 20497744
• Product Code: LMH
• UDI-Device Identifier: 07640173231653
• UDI-Public: 07640173231653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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 Expiration Date: 10/30/2024
• Device Model Number: RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
• Device Catalogue Number: 940056
• Device Lot Number: 22402DL0
• 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: 06/14/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2022
• 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 Age: 44 YR
• Patient Sex: Female