MAUDE Adverse Event Report: Q-MED RESTYLANE CONTOUR; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 19034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Necrosis (1971); Skin Discoloration (2074); Obstruction/Occlusion (2422)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious events of vascular occlusion and eschar and the non-serious events of bruising at implant site and livedo reticularis were considered expected and possibly related to the treatment.Serious criteria include the need for medical intervention to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion and subsequent ischemic manifestations.Potential contributory factor include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: restylane contour-no corrective or preventive actions are deemed necessary based on the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 22-dec-2021 by an other health professional which refers to a (b)(6) female patient.The patient's medical history included covid-19 on (b)(6) of an unknown year.The patient had no known allergies.No information about past filler treatments has been provided.On (b)(6) 2021, the patient had received first dose of moderna covid-19 vaccine and second dose on (b)(6) 2021.On (b)(6) 2021, the patient received treatment with 1 syringe restylane contour (lot 19034), half syringe to each side of malar area using an unspecified cannula with unknown injection technique to enhance malar area.On (b)(6) 2021, the patient had received the third dose of moderna covid-19 vaccine and flu vaccine.On (b)(6) 2021, the patient experienced a small area of bruising (implant site bruising) on left malar area.The patient was instructed to use ice over the next few days.The area was not white, had good capillary refill and no other evidence of vascular compromise.On (b)(6) 2021, the hcp believed that the patient had vascular occlusion (vascular occlusion).A week later, on an unknown date in (b)(6) 2021, the patient called hcp reporting that her bruise was getting worse.On examination, she had a resolving bruise but also an area of eschar (eschar) on the upper medial aspect of the left malar with mottled tissue (livedo reticularis) under it.The eschar was about 1 cm x 1/2 cm.On (b)(6) 2021, the hcp treated the area with hylenex [vorhyaluronidase alfa] (b)(4) units and had good capillary refill.Over the next 2 days, the area pinked up with no further signs of vascular compromise.After hylenex treatment, there was improvement.In addition, bacitracin [bacitran] ointment was applied to the area of eschar to keep soft and two days later, most of the eschar was gone.The patient was given cicalfate [cicalfate] to keep the area moistured.Outcome at the time of the report: eschar was recovering/resolving.Vascular occlusion was recovering/resolving.Bruising was recovering/resolving.Mottled tissue was recovering/resolving.Tracking list: v.0 initial, v.1 fu received on 23-dec-2021 from the same reporter.Case upgraded to serious.Events (eschar and livedo reticularis) were added.Patient demographics, medical history, past, concomitant medications, suspect device implant date, volume, needle type, lot number, expiry date, outcome, severity, reporter causality and corrective treatment details were updated.

• Brand Name: RESTYLANE CONTOUR
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 13286066
• MDR Text Key: 289066579
• Report Number: 1000118068-2022-00001
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Lot Number: 19034
• 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: 01/18/2022
• Distributor Facility Aware Date: 12/23/2022
• Event Location: Other
• Date Report to Manufacturer: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLU VACCINE; MODERNA COVID-19 VACCINE FIRST DOSE; MODERNA COVID-19 VACCINE SECOND DOSE; MODERNA VACCINE BOOSTER DOSE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female