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

Lot Number 17598

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

Patient Problem Occlusion (1984)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of vascular occlusion was considered possibly related to the treatment.Serious criteria include the need for medical intervention.Potential etiologies include intravascular injection of the gel leading to vascular occlusion.Potential contributory factors include injection technique.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.Manufacturer narrative: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by an other health professional which refers to a female patient of an unknown age.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with 1 ml restylane lyft with lidocaine (lot 17598) to unknown location (unknown needle type and injection technique).Same day, on (b)(6) 2020, the patient experienced possible occlusion(vascular occlusion) in the nose during injection and immediately injected hyaluronidase [hyaluronidase].The patient returned several hours later and received another dose of hyaluronidase.The patient was recovering.Outcome at the time of the report: possible occlusion was recovering/resolving.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• 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
• MDR Report Key: 10215476
• MDR Text Key: 197217304
• Report Number: 9710154-2020-00056
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Lot Number: 17598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• 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): Required Intervention