MAUDE Adverse Event Report: TEOXANE RHA2; RESILIENT HYALURONIC ACID

Lot Number 200911C0

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Pallor (2468)

Event Date 03/19/2021

Event Type  Injury  

Event Description

Vascular occlusion [vascular occlusion].Blanching [pallor].Bruising [injection site bruising].Hematoma [injection site haematoma].United states report received from a physician on (b)(6) 2021.A physician reported that a caucasian(b)(6) male patient received 0.1 ml rha2 to fill superficial lines and skin scarring on (b)(6) 2021; and frequency, was unknown.A volume of less than 0.1ml of rha2 was applied to the mid face (submalar region in patient's scar area) and cheeks using a fanning injection technique.It was unknown if a cannula was used for the administration of rha2.The product was injected using needles supplied from the box.Previous cosmetic procedures include rha3 injections on (b)(6) 2021 and (b)(6) 2020 and radiesse on (b)(6) 2020.Concomitant medications and food supplements were not provided.Medical history included alopecia areata and facial reconstruction surgery.The patient received 2 doses of covid-19 vaccine 4 weeks prior to rha2 injection.They physician was not sure which vaccine the patient received.On (b)(6) 2021, following the injection of rha2, the physician reported that patient experienced vascular occlusion and blanching of the skin.As treatment to reverse the occlusion, the physician applied 600 units of hylenex, warm compress, and nitropaste over 3 hours and approximately 2 hours later the area began to clear up.The physician clarified that she was surprised since the artery was so superficial.The physician also speculated that the reaction was that of bruising and hematoma, as the product was injected into a high-risk area.As treatment, the physician applied a warm compress and dissolved the filler with hyaluronidase.No further treatment was provided.The outcome of the events vascular occlusion and blanching was resolved on (b)(6) 2021.The outcome of the events bruising, and hematoma were unknown.The intensity of the events vascular occlusion and blanching were mild.The intensity of the events bruising, and hematoma was not provided.The product was available for return.(b)(4).No additional information was available at the time of this report.

• Brand Name: RHA2
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; lee charmilles; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 11680636
• MDR Text Key: 245970740
• Report Number: 3007772056-2021-00005
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021,03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 200911C0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2021
• Distributor Facility Aware Date: 03/19/2021
• Device Age: 0 YR
• Date Report to Manufacturer: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 77