MAUDE Adverse Event Report: TEOXANE RHA3; RESILIENT HYALURONIC ACID

Device Problem Off-Label Use (1494)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injection Site Reaction (4562)

Event Date 09/26/2021

Event Type  Injury  

Event Description

Allergy type symptoms [hypersensitivity] small nodules on her right cheek bone and in marionettes [injection site nodule] rha3 to the top and bottom lips; rha4 to the bilateral medial cheeks and chin [off label use] united states report received from a physician on (b)(6) 2021.A physician, who was also the injector, reported that a (b)(6) female patient received rha3 and rha4 for facial aging, wrinkles, and folds on (b)(6) 2021.An unknown volume of rha3 was applied to the patient's top and bottom lips using an unknown injection technique.A 25-gauge, 38 millimeter tsk steriglide, micro cannula was used for the administration of rha3.A volume of one syringe of rha4 was applied to each cheek and one syringe of rha4 was applied to each side of the chin and marionette lines using an unknown injection technique.A 25-gauge, 38 millimeter tsk steriglide, micro cannula was used for the administration of rha4.Previous cosmetic procedures and food supplements were not reported.The patient's medical history included allergies to penicillin, sulfa, and an environmental allergy.Concomitant medications included voluma and claritin-d (loratadine).On (b)(6) 2021, during the administration of rha3 and rha4, the patient also received voluma to the lateral cheeks.On (b)(6) 2021, approximately seven weeks after the administration of rha3 and rha4, the patient was reported to be fine.On (b)(6) 2021, the patient experienced allergy type symptoms that consisted of severe facial swelling over her entire face, including her eyes and a scratchy throat.The patient visited the emergency room and, as treatment, was given a steroid injection and a medrol dosepak (methylprednisolone) and was sent home.On (b)(6) 2021, the patient was seen by the injector who noted mild facial edema and could palpate some small nodules on the patient's right cheek bone and in her marionette lines.The nodules were non-tender and not red.The injector instructed the patient to finish her steroid treatment.On an unknown date in (b)(6) 2021, the patient finished her steroid treatment and experienced swelling again later the next day.As treatment, the patient took benadryl (diphenhydramine hcl) and iced the areas, which the patient reported helped the swelling minimally.The outcome of the event of hypersensitivity was ongoing.The outcome of the event of injection site nodule was not reported.The product was not available for return.(b)(4).No additional information was available at the time of this report.

• Brand Name: RHA3
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 12739353
• MDR Text Key: 279648690
• Report Number: 3007772056-2021-00021
• 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: 11/02/2021,10/04/2021

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2021
• Distributor Facility Aware Date: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CLARITIN-D (LORATADINE, PSEUDOEPHEDRINE SULFATE)
• Patient Outcome(s): Other
• Patient Age: 56 YR