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

Lot Number 16815-1

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

Patient Problems Embolism (1829); Erythema (1840); Granuloma (1876); Pain (1994); Pallor (2468); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The reported lot number was valid.Pharmacovigilance comment: the serious event of embolism arterial was considered expected and possibly related to the treatment.Serious criteria include the need for intervention to prevent permanent damage.The non-serious events of pallor, pain, livedo reticularis, granuloma skin and erythema at the implant site were considered expected and possibly related to the treatment.Potential etiologies of the events include injection of filler into blood vessel leading to embolism and its manifestations of pallor, pain, and livedo reticularis.Potential etiologies of the subsequent granulomas and erythema include inflammatory and infectious complications of the ischemic event.Potential contributory factors for late onset findings include persistence of the embolus since only led light therapy was reported as corrective therapy.Pulsed light might be used to remove discoloration associated with bruising or post-inflammatory hyperpigmentation.The case meets the criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 14-nov-2019 by a physician which refers to a (b)(6) female patient.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2019, the patient received treatment with 1 ml of restylane volyme (lot s2191070005) for filling of tear trough with unknown needle and injection technique.On (b)(6) 2019, the patient received treatment with 1 ml of restylane refyne (lot 16815-1) for filling of nasolabial folds with unknown needle and injection technique.An unknown time later, on an unknown date in 2019, the patient experienced embolization(embolism arterial) of the facial and nasal artery, bleaching(pallor), very intense pain(pain) hemifacially and livedo(livedo reticularis) of the upper left lip, nose and left cheekbone.No eye complications were reported.As corrective treatment, the patient underwent 5 sessions of led but the treatment stopped.After one month, on an unknown date in (b)(6) 2019, the patient experienced erythema(implant site erythema) and granulomas(granuloma skin) on the left side of nose area.Outcome at the time of the report: embolization was unknown.Very intense pain was unknown.Livedo was unknown.Bleaching was unknown.Erythema was unknown.Granulomas was unknown.

• Brand Name: RESTYLANE REFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 9458430
• MDR Text Key: 185930799
• Report Number: 9710154-2019-00109
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 16815-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 47 YR