MAUDE Adverse Event Report: TEOXANE RHA2; RESILIENT HYALURONIC ACID

Device Problem Off-Label Use (1494)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Vascular occlusion, vascular occlusion.Rha2 to the mid face, off label use.United states report received from other health care professional on 08-jun-2022.A registered nurse who was also the prescriber/injector, reported that a male patient of unknown age received rha2 for unknown indication on (b)(6) 2022 (dose and frequency not reported).An unknown volume of rha2 were applied to the mid face area using an unknown injection technique.It was unknown if the needle from the box was used for the administration or cannula was used for rha2 administered.Previous cosmetic procedures were not provided.No medical history was not provided.Concomitant medication and food supplement were not provided.On (b)(6) 2022, a patient was injected with an unknown amount of rha2 to the "mid face".On an unknown date in 2022, the patient had an "occlusion" at the injection site, that was described as in red color.The area was flushed with hyaluronidase as treatment.The event resolved on an unknown date in 2022.The outcome of the event was recovered the intensity of the event was not provided.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 the rha2 and 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 reported information.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-12 03; SZ CH-1203
• MDR Report Key: 14882271
• MDR Text Key: 295119171
• Report Number: 3007772056-2022-00014
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/01/2022,06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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: 07/01/2022
• Distributor Facility Aware Date: 06/08/2022
• Device Age: 0 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Race: White