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

Lot Number 18393

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

Patient Problems Ecchymosis (1818); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of vascular occlusion was considered expected and possibly related to the treatment. Serious criteria include the need for medical intervention with multiple hyaluronidase treatments to prevent permanent damage. The likely root cause include intravascular filler injection leading to vascular occlusion. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations. Manufacturer narrative: 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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-mar-2021 by another health professional which refers to an adult patient of unknown 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 kysse (unknown amount, lot number, injection technique and needle type) to unknown location. Unknown time later, on an unknown date, the patient experienced vascular occlusion. On an unknown date, the patient was treated with multiple flushes of hylenex [hyaluronidase]. Outcome at the time of the report: vascular occlusion was unknown.

• Brand Name: RESTYLANE KYSSE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11578490
• MDR Text Key: 259125972
• Report Number: 1000118068-2021-00010
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2022
• Device Lot Number: 18393
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Distributor Facility Aware Date: 03/19/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/19/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/27/2021 Patient Sequence Number: 1