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

Lot Number UNKNOWN

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

Patient Problems Ischemia (1942); Pain (1994); Skin Discoloration (2074); Skin Erosion (2075); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious event of ischaemia at implant site and the non-serious events of livedo reticularis, pustules, pain and erosion at implant site were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion and 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.Lot number was not reported and the product could not be verified.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: 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 28-jan-2022 by a physician which refers to a female patient of an unknown age.Additional information was received on 31-jan-2022 and 01-feb-2022 from the same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2022 the patient received treatment with restylane refyne to glabellar region (unknown amount, lot number, injection technique and needle type).The procedure was guided by ultrasound.On (b)(6) 2022 the patient experienced erythematosus livedo reticularis (livedo reticularis) at the region of frontal vessels extending to nasal dorsum.As a corrective treatment predsim [prednisolone sodium phosphate] 40 mg and aspirin [acetylsalicylic acid] 300 mg were prescribed on the same day.On (b)(6) 2022 due to the events urgency, the patient also received hyaluronidase [hyaluronidase] injection.On (b)(6) 2022 the patient was still experiencing livedo.The patient also experienced some pustules (implant site pustules) in nasal dorsum and glabellar region.On (b)(6) 2022 the patient received treatment with hyaluronidase injection at a dosage of 3000 u at the local area.On (b)(6) 2022 the patient experienced a worsening of clinical condition and more pustules concentrated in glabellar region.Corrective treatments included hyaluronidase injection guided by ultrasound at a dosage of 9000 u.In (b)(6) 2022 , the patient experienced pain (implant site pain) and ischaemia (implant site ischaemia).On (b)(6) 2022 the patient experienced skin erosion (implant site erosion) at glabella and new pustules at frontal.Corrective treatments included hyperbaric camera to help the recovering of the area which already had suffered from ischemia, due to the possibility of necrosis and to prevent the new necrotic areas in unobstructed regions yet.On (b)(6) 2022 the patient was still experiencing closed livedo.Corrective treatments included hyaluronidase injection guided by ultrasound and of hyperbaric camera session on the same day.On (b)(6) 2022 the patient was still experiencing pain on palpation; finger pressure of some regions was performed and a new hyaluronidase injection was performed.Until the time of report, a total dose of 25,500 u of hyaluronidase had been injected, treatment with predsim and aspirin was ongoing and local cares was being performed.The patient was still requiring hyperbaric camera treatment and ophthalmological evaluation.On an unknown date in (b)(6) 2022 the patient underwent optical coherence tomographs (oct) and results were normal.According to the reporter, the patient required work leave as the case was potentially serious.Corrective treatment required included several hyaluronidase injections, in addition to ultrasound exams, oct, hyperbaric camera and multi wave led.As of (b)(6) 2022 the patient was recovered from all events.The reporter confirmed that the patient did not experience necrosis, she was having good healing and was living a normal life.Outcome at the time of the report: ischemia was recovered/resolved.Erythematosus livedo reticularis was recovered/resolved.Pustules was recovered/resolved.Pain was recovered/resolved.Skin erosion was recovered/resolved.

• Brand Name: RESTYLANE REFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 13517044
• MDR Text Key: 289880689
• Report Number: 9710154-2022-00003
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female