MAUDE Adverse Event Report: TEOXANE RHA2; RESILIENT HYALURONIC ACID

Lot Number G10 (01) 07640173230014

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Skin Infection (4544)

Event Date 02/17/2021

Event Type  Injury  

Event Description

Herpetic infection [oral herpes], bruise and looked dark and dusty; vascular occlusion/compression in a small branch of the superior labial artery [vascular occlusion], plunger puller out upon aspiration [device connection issue], injected in right upper lip [off label use].United states report from a nurse on (b)(6) 2021.A nurse reported that a (b)(6) female received rha2 on (b)(6) 2021 with unknown dose and frequency.The patient was injected with 1 syringe of rha2 in the right upper lip.The technique used for administration of rha2 was unknown.It was not reported whether a cannula was used for administration.Previous cosmetic procedures of juvaderm was last injected approximately 1 ½ yrs ago.Medical history included herpes infection and concomitant medications and food supplements were not provided.On (b)(6) 2021, 24 hours post injection, the patient developed symptoms of "significant" herpetic infection with pain and lips began bruise and look dark and dusty, and no swelling.The patient experienced a vascular occlusion/compression in a small branch of the superior labial artery.The patient did not have any pain from the occlusion.Treatment included valtrex, aspirin, and a warm compress.Two days later, the area had not lightened up and still looked mottled.Then it was decided to dissolve the filler with 200units of vitrase and saline to the right upper lip.After dissolving the filler, the area improved significantly and now the patient had a faint "purple hue." the outcome of the events was recovering.It was unknown if the product was available for return.(b)(4) no additional information was available at the time of this report.

• Brand Name: RHA2
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyons, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 11517564
• MDR Text Key: 245431789
• Report Number: 3007772056-2021-00003
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: G10 (01) 07640173230014
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2021
• Device Age: 0 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR