MAUDE Adverse Event Report: TEOXANE RHA3; RESILIENT HYALURONIC ACID

Catalog Number 940008

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Swelling/ Edema (4577)

Event Date 11/09/2020

Event Type  Injury  

Event Description

United states report received from a nurse, who is also the patient, via consultant on (b)(6) 2020.An adult female patient (age unknown) received rha3 on (b)(6) 2020 in order to treat dynamic folds and wrinkles during a singular session.Dose was not reported.The patient was injected with half a syringe of rha3 in the bilateral nasolabial folds and lateral malar cheek area of the face, using a linear threading, fanning technique.A total of two, 1.5 syringes were used.Volume was not reported.It was not reported whether a cannula was used for administration.Previous cosmetic procedures were unknown/not provided.Medical history included administration of xeomin (incobotulinumtoxina).Concomitant medications and food supplements were not provided.On the morning of (b)(6) 2020, 4 days following injection of rha3, the patient noticed a red and swollen area under the eye, which was clarified as right tear trough swelling at least one inch away from the injection site.Swelling was also noted in the right upper eyelid.The swelling was erythematous and warm, but was not painful nor was it accompanied by fever, chills or systemic signs of infection.This was clarified by the nurse practitioner to likely be an inflammatory reaction.By 8:00 pm on (b)(6) 2020, the patient noticed increased unilateral swelling around her right eye and she self-administered keflex (cefalexin) 500 milligram (mg) and allegra (fexofenadine).At bedtime on (b)(6) 2020, the swelling intensified further and she took an additional dose of keflex 500 mg.In the morning on 10-nov-2020, because of persistent swelling, the patient took an additional dose of keflex 500 mg and an additional fexofenadine and started a solu-medrol dose pack (methylprednisolone).By 12-nov-2020, the swelling was much improved and the erythema and warmth had disappeared.The patient continued tapering her glucocorticoid and continued on daily fexofenadine.She treated the remaining swelling with self-massage.The swelling continued to improve and as (b)(6) 2020, the swelling is reported to be at least 90% resolved.The patient did not believe she had an injection site infection.Instead she believed she had an inflammatory reaction responsive to glucocorticoid.The patient planned to continue to monitor her progress.The outcome of the events was resolving.The product was not available for return.(b)(4).This case is linked to us: (b)(4) (same patient).The patient was injected with rha3 and rha4 and experienced the adverse events described in this report and the linked report(s) to comply with medical device regulatory reporting requirements.No additional information was available at the time of the 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: 10979426
• MDR Text Key: 220639791
• Report Number: 3007772056-2020-00004
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/09/2020,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Catalogue Number: 940008
• Device Lot Number: (10)200711AO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2020
• Distributor Facility Aware Date: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 54