MAUDE Adverse Event Report: TEOXANE RHA2; RESILIENT HYALURONIC ACID

Device Problem Off-Label Use (1494)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/11/2022

Event Type  Injury  

Event Description

Vascular occlusion or very bad bruise [vascular occlusion], rha2 in the lip or around the mouth [off label use].United states report received from a healthcare professional on (b)(6) 2022.A nurse who was also the injector reported that a female patient of an unknown age had received rha2 product for unknown indication, in (b)(6) 2022.An unknown volume of rha2 injection was applied to the lips or around the mouth (as mentioned not sure of the injection site) using an unknown injection technique.It was unknown if the needle was used from the box and cannula was used for the administration of the rha2 product.No previous cosmetic procedures were done.Medical history was not provided.Concomitant medications, and food supplements were not provided.It was unknown if any concomitant fillers and previous facial fillers were used.On 11-aug-2022, after an unspecified time, the patient experienced vascular occlusion or very bad bruise.As a treatment, the prescriber applied heat, massage and was dissolved now.The outcome of the event was not reported.The product was not available for return.The intensity of the event was not reported.(b)(4).No additional information was available at the time of this report.Case comment: a causal relationship between the rha2 and reported vascular occlusion is assessed as possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the limited information reported.The company will continue monitoring the benefit-risk profile for the product.

• Brand Name: RHA2
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyon, 105; geneva, ch 1203 ; SZ 1203
• MDR Report Key: 15364296
• MDR Text Key: 299357289
• Report Number: 3007772056-2022-00018
• 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: 09/06/2022,08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Distributor Facility Aware Date: 08/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female