MAUDE Adverse Event Report: TEOXANE RHA3; RESILIENT HYALURONIC ACID

Device Problem Off-Label Use (1494)

Patient Problem Granuloma (1876)

Event Type  Injury  

Event Description

United states report received from a healthcare professional on 10-mar-2022.A nurse who was also the injector and prescriber reported that a female patient of unknown age received rha3 for lip augmentation, on an unknown date in (b)(6) 2021; dose and frequency were not reported.An unknown volume of rha3 injection was applied to the lips using an unknown injection technique.It was unknown if the cannula or the needle were used from the box.Previous cosmetic procedures were not provided.Concomitant medications, and food supplements were not provided.On an unknown date, an unknown period following injection of rha3, the patient appeared with a "granuloma" on the lip, unknown if top or bottom.The event is still ongoing, and it is unknown if there has been any treatment given.The outcome of the events was not recovered/not resolved.The product was not available for return.(b)(4).No additional information was available at the time of this report.Case comment: a causal relationship between rha3 and granuloma on the lip is assessed possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the reported information."granuloma" is a known side effect of rha3, and it tends to occur with relatively long latent time, i.E., weeks or months post injection.Note is made in this case that no biopsy was reported to have been done, thus makes the reported "granuloma" unconfirmed with histological examination.The company will continue monitoring the benefit-risk profile for the rha3.

• 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: 14017852
• MDR Text Key: 288785611
• Report Number: 3007772056-2022-00006
• 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
• Type of Report: Initial
• Report Date: 04/05/2022,03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 04/05/2022
• Distributor Facility Aware Date: 03/10/2022
• Device Age: 0 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female