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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: although not many details reported (e.G.No information on age and gender), the serious expected event of vascular occlusion was considered possibly related to the treatment.Serious criteria include the need for medical interventions to prevent permanent damage and hospitalization.The likely root cause for the reported event is the user error of intravascular filler injection leading to vascular occlusion.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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.Lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-nov-2020 by a physician which refers to a patient of an unknown age and gender.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date, the patient received treatment with restylane nos (unknown amount, lot number, injection technique and needle type) for filling of the nasogenian sulcus.3 hours later, on an unknown date, the patient experienced alterations, angular vein obstruction (vascular occlusion).48 hours after the procedure, the patient returned to medical consultation.As a corrective treatment, the patient received hyaluronidase [hyaluronidase], clexane [enoxaparin sodium] and aas [acetylsalicylic acid], but without improvement.On unknown date, the patient underwent to ultrasound not for diagnostic purpose but performed hyaluronidase infiltration.According the reporter, patient started receiving treatment 72 hours after the procedure.On unknown date, the patient was hospitalized and received injection of hyaluronidase and prostaglandin [alprostadil].Outcome at the time of the report: alterations, angular vein obstruction was unknown.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 10877578
• MDR Text Key: 217932419
• Report Number: 9710154-2020-00095
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040024
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• 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): Hospitalization; Required Intervention